Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Numbe...
FDA Device Recall #Z-1421-2026 — Class II — January 7, 2026
Recall Summary
| Recall Number | Z-1421-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 7, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 117907 units |
Product Description
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65
Reason for Recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Distribution Pattern
Worldwide distribution - US Nationwide.
Lot / Code Information
1) CDS940087AG, UDI-DI: 10193489847260(each), 40193489847261(case), Lot Number: 21EBC900; 2) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22GBE442; 3) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBG548; 4) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBF695; 5) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBA274; 6) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22BBY060; 7) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21KBH163; 8) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21JBF936; 9) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21IBJ260; 10) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21GBI183; 11) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21FBS254; 12) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21BBL223; 13) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21LBO219; 14) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBQ650; 15) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBB625; 16) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBV695; 17) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBU197; 18) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21GBR895; 19) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23JBI054; 20) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23GBP400; 21) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23EBW653; 22) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23DBR887; 23) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23CBG614; 24) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBK758; 25) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBJ844; 26) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBK666; 27) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBI093; 28) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22JBH355; 29) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22HBS531; 30) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBM598; 31) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBL549; 32) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK859; 33) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK858; 34) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBL968; 35) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBC616; 36) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21KBF393; 37) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21JBO077; 38) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBV804; 39) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBB808; 40) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23EBK295; 41) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23CBT556; 42) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23BBP326; 43) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABH483; 44) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABG351; 45) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22IBE748; 46) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS173; 47) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS172; 48) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22FBD583; 49) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22DBN516; 50) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 21LBW480; 51) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21FBH003; 52) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21ABX303; 53) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22OBL581; 54) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22IMH323; 55) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22GBM603; 56) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22FBO257; 57) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22DBD515; 58) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21VBC540; 59) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21JBA989; 60) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21JBA988; 61) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21IBP619; 62) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23FMI799; 63) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23EME858; 64) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23DMF336; 65) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23DMB940; 66) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23CMA547; 67) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24IMH073; 68) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24HMH806; 69) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24FMG472; 70) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24EMC301; 71) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24CMC328; 72) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24AMG267; 73) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23KMH550; 74) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23IMA365; 75) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23HMF744; 76) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24DMH818; 77) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24CMC092; 78) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24BMF152; 79) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24AMB397; 80) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23FME101; 81) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23EMG643; 82) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23DMH779; 83) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23CMF017; 84) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23CMB403; 85) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 25BMJ035; 86) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 25AMJ535; 87) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24LMC844; 88) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24KMB678; 89) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24JMB660; 90) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24GMI703; 91) CDS981502K, UDI-DI: 10195327295370(each), 40195327295371(case), Lot Number: 24CMF795; 92) CDS981502K, UDI-DI: 10195327295370(each), 40195327295371(case), Lot Number: 23JMI916; 93) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22KBM385; 94) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22JBK515; 95) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22IBJ349; 96) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22HBQ624; 97) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22HBN671; 98) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22FBS293; 99) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22ABS105; 100) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 24BBH054; 101) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 24ABU182; 102) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23KBQ766; 103) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23KBQ737; 104) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23GBG193; 105) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23DBL133; 106) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23CBU775; 107) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23CBI326; 108) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23ABG957; 109) CDS981505Q, UDI-DI: 10198459028991(each), 40198459028992(case), Lot Number: 24IBD132; 110) CDS981505Q, UDI-DI: 10198459028991(each), 40198459028992(case), Lot Number: 24GBJ138; 111) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 25DBO814; 112) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 25BBD996; 113) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 24LBR473; 114) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 24KBP956; 115) CDS981858F, UDI-DI: 10889942973682(each), 40889942973683(case), Lot Number: 21ABH636; 116) CDS982035W, UDI-DI: 10193489999259(each), 40193489999250(case), Lot Number: 22HBP524; 117) CDS982035W, UDI-DI: 10193489999259(each), 40193489999250(case), Lot Number: 22GBI202; 118) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 23AMB059; 119) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 22LMB455; 120) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 22CME430; 121) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 25BMC093; 122) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24FMA426; 123) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24EMD974; 124) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24CMB637; 125) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24AMD955; 126) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 23IMF292; 127) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 23HME111; 128) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25LME952; 129) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25LMD470; 130) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25KMJ877; 131) CDS983036K, UDI-DI: 10193489842012(each), 40193489842013(case), Lot Number: 23KBN289; 132) CDS983042K, UDI-DI: 10193489842029(each), 40193489842020(case), Lot Number: 23KBN273; 133) CDS983049K, UDI-DI: 10193489841657(each), 40193489841658(case), Lot Number: 23JBY028; 134) CDS983049K, UDI-DI: 10193489841657(each), 40193489841658(case), Lot Number: 23JBX571; 135) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21JBY974; 136) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21JBD011; 137) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21HBK744; 138) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21DBH504; 139) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 21CBT358; 140) CDS983182G, UDI-DI: 10193489362480(each), 40193489362481(case), Lot Number: 20LBW136; 141) CDS983297M, UDI-DI: 10193489425857(each), 40193489425858(case), Lot Number: 21FDA407; 142) CDS983480G, UDI-DI: 10195327497842(each), 40195327497843(case), Lot Number: 24CDB716; 143) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 25BMI188; 144) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 24CMA539; 145) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 24AME511; 146) CDS983581K, UDI-DI: 10195327295448(each), 40195327295449(case), Lot Number: 23IMA904; 147) CDS983838G, UDI-DI: 10193489600360(each), 40193489600361(case), Lot Number: 21ADB812; 148) CDS983840I, UDI-DI: 10193489405668(each), 40193489405669(case), Lot Number: 21FDA409; 149) CDS983863D, UDI-DI: 10889942570980(each), 40889942570981(case), Lot Number: 22KDB188; 150) CDS983863D, UDI-DI: 10889942570980(each), 40889942570981(case), Lot Number: 22JDB465; 151) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 23EBK642; 152) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 23ABM823; 153) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22LBO557; 154) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22KBS560; 155) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22HBT635; 156) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22EBV412; 157) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22ABS153; 158) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 22ABP297; 159) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21JBK128; 160) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21IBA056; 161) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21DBU793; 162) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21CBF370; 163) CDS983879C, UDI-DI: 10193489435054(each), 40193489435055(case), Lot Number: 21CBC111; 164) CDS983903D, UDI-DI: 10198459053474(each), 40198459053475(case), Lot Number: 24HBQ596; 165) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21EBR750; 166) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21DBI790; 167) CDS984147K, UDI-DI: 10193489245424(each), 40193489245425(case), Lot Number: 21CBJ921; 168) CDS984156L, UDI-DI: 10193489245370(each), 40193489245371(case), Lot Number: 21DBQ627; 169) CDS984156L, UDI-DI: 10193489245370(each), 40193489245371(case), Lot Number: 21CBJ888; 170) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22KBP500; 171) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22HBP143; 172) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22GBO260; 173) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22EBJ581; 174) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22CBW600; 175) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 22BBX356; 176) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21KBY807; 177) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21HBM083; 178) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21GBU901; 179) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21FBL924; 180) CDS984254K, UDI-DI: 10193489289091(each), 40193489289092(case), Lot Number: 21CBD679; 181) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23EBJ573; 182) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23DBD812; 183) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23CBR791; 184) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23BBS246; 185) CDS984254L, UDI-DI: 10195327298159(each), 40195327298150(case), Lot Number: 23ABK592; 186) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25KBK734; 187) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25IBW208; 188) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 25GBG607; 189) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24KBJ956; 190) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24IBP093; 191) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24IBB732; 192) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24GBU116; 193) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24GBB449; 194) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24EBF862; 195) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24DBS099; 196) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24BBS781; 197) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 24ABT691; 198) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 23JBT902; 199) CDS984254M, UDI-DI: 10195327415242(each), 40195327415243(case), Lot Number: 23HBV822; 200) CDS984527I, UDI-DI: 10193489376739(each), 40193489376730(case), Lot Number: 21BDA355; 201) CDS984607G, UDI-DI: 10889942719389(each), 40889942719380(case), Lot Number: 21EBC029; 202) CDS984607G, UDI-DI: 10889942719389(each), 40889942719380(case), Lot Number: 21ABV551; 203) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23DBK552; 204) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23BBU944; 205) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23ABE701; 206) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 23ABA744; 207) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22JBQ863; 208) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22JBH295; 209) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22IBP797; 210) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22IBO809; 211) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22HBJ382; 212) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22GBF580; 213) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBS549; 214) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBR470; 215) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22EBQ393; 216) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 22CBP419; 217) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21VBC530; 218) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21LBE361; 219) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21JBM719; 220) CDS984607I, UDI-DI: 10193489959482(each), 40193489959483(case), Lot Number: 21IBK997; 221) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 23BBG636; 222) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 23ABF816; 223) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22OBI284; 224) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22KBB895; 225) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22GBU468; 226) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22FBK619; 227) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 22BBL459; 228) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 21LBQ977; 229) CDS984610C, UDI-DI: 10193489959505(each), 40193489959506(case), Lot Number: 21IBV618; 230) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 24BBB251; 231) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23LBV047; 232) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23LBI902; 233) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23KBB103; 234) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23HBH071; 235) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23FBV622; 236) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23FBE479; 237) CDS985202B, UDI-DI: 10889942942053(each), 40889942942054(case), Lot Number: 23BBS726; 238) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 25BBD069; 239) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24LBI139; 240) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24JBU521; 241) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24JBM801; 242) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24EBR586; 243) CDS985202C, UDI-DI: 10195327661908(each), 40195327661909(case), Lot Number: 24DBD819; 244) CDS985279K, UDI-DI: 10195327497460(each), 40195327497461(case), Lot Number: 24CDA763; 245) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23GBT765; 246) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23DBD828; 247) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23CBP302; 248) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 23ABC226; 249) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22NBE575; 250) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22LBT331; 251) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22JBR384; 252) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22GBU431; 253) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBQ646; 254) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBM692; 255) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 22FBB121; 256) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21LBI665; 257) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21LBH556; 258) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21GBL257; 259) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21CBM829; 260) CDS985316A, UDI-DI: 10888277077553(each), 40888277077554(case), Lot Number: 21ABP208; 261) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24IBU020; 262) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24GBW059; 263) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24FBN572; 264) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24DBF304; 265) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24BBO443; 266) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 24ABT609; 267) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 23JBS895; 268) CDS985317C, UDI-DI: 10195327477837(each), 40195327477838(case), Lot Number: 23IBA494; 269) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 25CBV211; 270) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 25BBD080; 271) CDS985317D, UDI-DI: 10198459152450(each), 40198459152451(case), Lot Number: 24LBD251; 272) CDS985317F, UDI-DI: 10198459309311(each), 40198459309312(case), Lot Number: 25HBD051; 273) CDS985317F, UDI-DI: 10198459309311(each), 40198459309312(case), Lot Number: 25FBK413; 274) CDS985317G, UDI-DI: 10198459509063(each), 40198459509064(case), Lot Number: 25LBC622; 275) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 23ABE885; 276) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 22KBC308; 277) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 21CBU636; 278) CDS985425J, UDI-DI: 10193489318890(each), 40193489318891(case), Lot Number: 21CBH306; 279) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25KDA137; 280) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25GDA910; 281) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25DDB938; 282) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 25ADB448; 283) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24IDA344; 284) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24HDA224; 285) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 24ADA064; 286) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23JDB638; 287) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23CDB828; 288) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23BDB741; 289) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 23ADB631; 290) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22JDB343; 291) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22FDB552; 292) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 22EDA009; 293) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21HDC208; 294) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21ADB694; 295) CDSOPM834W, UDI-DI: 10193489748758(each), 40193489748759(case), Lot Number: 21ADA639; 296) DYKM1161, UDI-DI: 10888277838529(each), 40888277838520(case), Lot Number: 23ABS895; 297) DYKM2106, UDI-DI: 10195327020736(each), 40195327020737(case), Lot Number: 22FBT157; 298) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 25CBT503; 299) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24HBH168; 300) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24GBC828; 301) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24FBB726; 302) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24BBJ839; 303) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 24ABH888; 304) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22KBO875; 305) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22JBP430; 306) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22IBS840; 307) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22FBI537; 308) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22FBF302; 309) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22DBM212; 310) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 22CBB535; 311) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21HBG593; 312) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21HBF503; 313) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21EBE678; 314) DYKMBNDL137, UDI-DI: 10193489478143(each), 40193489478144(case), Lot Number: 21ABM611; 315) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25GBP632; 316) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25FBU008; 317) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25FBK659; 318) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25EBK537; 319) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25BBI466; 320) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25ABS680; 321) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 25ABQ126; 322) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24KBQ931; 323) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24IBE136; 324) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24GBV669; 325) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 24GBH578; 326) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23LBO287; 327) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23KBV904; 328) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23JBB704; 329) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23HBY495; 330) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23HBH773; 331) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23GBJ242; 332) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23FBE416; 333) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23EBL742; 334) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23DBL148; 335) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 23ABK726; 336) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 22JBG015; 337) DYKMBNDL138A, UDI-DI: 10195327240691(each), 40195327240692(case), Lot Number: 22JBF639; 338) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22HBQ237; 339) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22FBS797; 340) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBS811; 341) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBQ939; 342) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBQ935; 343) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22EBF963; 344) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22CBV519; 345) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22BBR667; 346) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 22ABL303; 347) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21VBB503; 348) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21IBK151; 349) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21IBJ315; 350) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21GBO489; 351) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21GBJ360; 352) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21FBF908; 353) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21EBM705; 354) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBJ601; 355) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBF326; 356) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21CBB270; 357) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21BBF813; 358) DYKMBNDL141, UDI-DI: 10193489478181(each), 40193489478182(case), Lot Number: 21ABL153; 359) DYKMBNDL141A, UDI-DI: 1019532724776
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.