Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY C...
FDA Device Recall #Z-1415-2026 — Class II — January 7, 2026
Recall Summary
| Recall Number | Z-1415-2026 |
| 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 | 12418 units |
Product Description
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 14) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 15) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 16) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 17) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 18) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 19) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 20) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; 21) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92; 22) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92A; 23) KIT GYN ABDOMINAL, Model Number: DYKMBNDL92C; 24) KIT GYN LAP, Model Number: DYKMBNDL94; 25) KIT GYN LAP, Model Number: DYKMBNDL94A; 26) KIT GYN LAP, Model Number: DYKMBNDL94C; 27) KIT GYN LAP, Model Number: DYKMBNDL94D; 28) GYN LAPAROSCOPY PACK-LF, Model Number: DYNJ0281948N; 29) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372F; 30) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372G; 31) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372I; 32) HEALTH ALL GYN LAP PACK-LF, Model Number: DYNJ28252G; 33) GYN OPERATIVE LAP PACK-LF, Model Number: DYNJ30005G; 34) OB PACK, Model Number: DYNJ32706B; 35) ROBOTIC UROLOGY-RF, Model Number: DYNJ38844N; 36) ENSEMBLE GYNE LAPAROTOMIE-LF, Model Number: DYNJ47550C; 37) GYN LAP PACK, Model Number: DYNJ47714A; 38) TASC GYN LAP, Model Number: DYNJ49191B; 39) ROBOTIC PACK, Model Number: DYNJ49705K; 40) GYN LAPAROSCOPY PACK, Model Number: DYNJ50348F; 41) NWH GYN LAPAROSCOPY, Model Number: DYNJ50439F; 42) FH LAPAROSCOPIC GYN PK-LF, Model Number: DYNJ51795F; 43) GYN LAPAROSCOPY PACK, Model Number: DYNJ52569B; 44) LAVH PACK, Model Number: DYNJ55862; 45) PK, GEN-LAPAROSCOPY, Model Number: DYNJ57607A; 46) GYN LAPAROSCOPY MRNGSD, Model Number: DYNJ58321A; 47) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079B; 48) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079C; 49) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079D; 50) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079F; 51) GYN DAVINCI PACK, Model Number: DYNJ64266; 52) DAVINCI PACK, Model Number: DYNJ66298D; 53) GYN LAPAROSCOPY, Model Number: DYNJ67269; 54) GENERAL GYN PACK, Model Number: DYNJ68710; 55) LAP GYN PACK, Model Number: DYNJ69419A; 56) LAP GYN PACK, Model Number: DYNJ69419D; 57) GYN LAPAROSCOPY, Model Number: DYNJ81492A; 58) PK, ROBOTIC GYN & GU-ROSE MEDI, Model Number: DYNJ81761A; 59) GYN PACK, Model Number: DYNJ83475A; 60) ROBOTIC XI PACK, Model Number: DYNJ84783; 61) GYN PACK, Model Number: DYNJ86195A; 62) GYN LAPAROSCOPY, Model Number: DYNJ900262A; 63) D&C HYSTEROSCOPY, Model Number: DYNJ901133A; 64) GYN LAPAROSCOPY, Model Number: DYNJ901559J; 65) GYN ENDOSCOPY-LF, Model Number: DYNJ901812J; 66) GYN LITHOTOMY-LF, Model Number: DYNJ902711M; 67) GENERAL ROBOTIC, Model Number: DYNJ905066B; 68) TRINITY C-SEC W/LINEN CDS, Model Number: DYNJ905269G; 69) KIT GYN LAPAROSCOPY RFD, Model Number: DYNJ906322D; 70) GYN LAP LH, Model Number: DYNJ906452C; 71) GYN LAP LH, Model Number: DYNJ906452D; 72) GYN LAP LH, Model Number: DYNJ906452F; 73) FLOYD LITH GYN, Model Number: DYNJ906926B; 74) GYN LAPAROSCOPY-MRMC, Model Number: DYNJ907753F; 75) GYN LAPAROSCOPY-SFMC, Model Number: DYNJ907771C; 76) LAP/GYN ROBOTICS, Model Number: DYNJ908887B; 77) LAP/GYN ROBOTICS, Model Number: DYNJ908887C;
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) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case), Lot Number: 24IBO240; 2) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case), Lot Number: 21CDB781; 3) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBX440; 4) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBN644; 5) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23ABC549; 6) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22OBM422; 7) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22KBD152; 8) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22JBC547; 9) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22HBV491; 10) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22GBP114; 11) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22FBV462; 12) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22BBL450; 13) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21VBA272; 14) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21IBM804; 15) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21HBN807; 16) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21GBI171; 17) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21EBA117; 18) CDS984543D, UDI-DI: 10195327072322(each), 40195327072323(case), Lot Number: 22CBC587; 19) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22OBL925; 20) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22KMD619; 21) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22JMA223; 22) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMG671; 23) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMB259; 24) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22GBD616; 25) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24BMH483; 26) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23LMA864; 27) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23JMC376; 28) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23IMA629; 29) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMH282; 30) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMF425; 31) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23FMI171; 32) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23EMI460; 33) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23DMA508; 34) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23CMC582; 35) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23BMD680; 36) CDS984543I, UDI-DI: 10195327637071(each), 40195327637072(case), Lot Number: 24CMH050; 37) CDS984860F, UDI-DI: 10193489261974(each), 40193489261975(case), Lot Number: 21ADB205; 38) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21DBV243; 39) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH547; 40) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH282; 41) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25LBN225; 42) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25HBS386; 43) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25FBS108; 44) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25DBN805; 45) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21JBD206; 46) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21GBP406; 47) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21EBA097; 48) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21BBG514; 49) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21ABI962; 50) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABW347; 51) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABO060; 52) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABM086; 53) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24DBA349; 54) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24CBF889; 55) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24JBB328; 56) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24IBV184; 57) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24GBK948; 58) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24FBC411; 59) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24DBS388; 60) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22HBL832; 61) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22FBI695; 62) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22CBX517; 63) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22BBR618; 64) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBY301; 65) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBP646; 66) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBX803; 67) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBC127; 68) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21HBK337; 69) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21FBP762; 70) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21EBG218; 71) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBP181; 72) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBA024; 73) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABL615; 74) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABJ213; 75) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25HBB957; 76) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25GBX843; 77) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25FBR662; 78) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBI207; 79) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBF533; 80) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24JBD270; 81) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24DBV608; 82) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24CBJ465; 83) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24ABX678; 84) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23LBE369; 85) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23KBA328; 86) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 22JBC546; 87) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22HBP253; 88) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22CBX518; 89) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL299; 90) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL283; 91) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21KBQ606; 92) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21JBJ225; 93) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21IBL095; 94) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBU222; 95) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBP369; 96) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21EBK837; 97) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21BBG518; 98) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21ABI984; 99) DYKMBNDL168A, UDI-DI: 10195327240806(each), 40195327240807(case), Lot Number: 23FBJ346; 100) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBQ333; 101) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBG179; 102) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25HBC798; 103) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25FBJ143; 104) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25BBF014; 105) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25ABS671; 106) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24HBK278; 107) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBV008; 108) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBJ568; 109) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22HBB985; 110) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22GBZ017; 111) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21LBJ751; 112) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21IBO770; 113) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21HBK341; 114) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21FBP714; 115) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21BBG520; 116) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21ABJ086; 117) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22HLA664; 118) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ELB163; 119) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ELA227; 120) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22DLB036; 121) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22CLA119; 122) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22BLA918; 123) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ALA331; 124) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ALA125; 125) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA284; 126) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA163; 127) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21JLA896; 128) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21HLA598; 129) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA658; 130) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA352; 131) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA256; 132) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21DLA017; 133) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21BLA496; 134) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ABJ861; 135) DYKMBNDL92A, UDI-DI: 10195327241209(each), 40195327241200(case), Lot Number: 22KLA731; 136) DYKMBNDL92A, UDI-DI: 10195327241209(each), 40195327241200(case), Lot Number: 22JLA665; 137) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25ILA134; 138) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25HLA275; 139) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25GLA701; 140) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25ELA660; 141) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25DLB036; 142) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 25BLA797; 143) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLB092; 144) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLA506; 145) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24KLA194; 146) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24JLB140; 147) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24JLA881; 148) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24HLB219; 149) DYKMBNDL92C, UDI-DI: 10198459000645(each), 40198459000646(case), Lot Number: 24HLB142; 150) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 22HBH516; 151) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 22FBK394; 152) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21IBV704; 153) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21HBO271; 154) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21GBB013; 155) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21CBS045; 156) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21CBB287; 157) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 21ABM148; 158) DYKMBNDL94, UDI-DI: 10193489477894(each), 40193489477895(case), Lot Number: 20LBY985; 159) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23BBI491; 160) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABO813; 161) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABK219; 162) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 23ABJ591; 163) DYKMBNDL94A, UDI-DI: 10195327241216(each), 40195327241217(case), Lot Number: 22LBS837; 164) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25CBR621; 165) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25BBA805; 166) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25ABN371; 167) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 25ABH279; 168) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24LBN994; 169) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24KBA746; 170) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24IBE086; 171) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24EBV430; 172) DYKMBNDL94C, UDI-DI: 10198459000669(each), 40198459000660(case), Lot Number: 24DBR903; 173) DYKMBNDL94D, UDI-DI: 10198459350641(each), 40198459350642(case), Lot Number: 25EBN175; 174) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24HBX130; 175) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24HBA113; 176) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24EBT021; 177) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24EBM495; 178) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24DBL074; 179) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24CBM999; 180) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24BBH633; 181) DYNJ0281948N, UDI-DI: 10195327600259(each), 40195327600250(case), Lot Number: 24ABI719; 182) DYNJ0347372F, UDI-DI: 10195327213176(each), 40195327213177(case), Lot Number: 22GBR392; 183) DYNJ0347372G, UDI-DI: 10195327266028(each), 40195327266029(case), Lot Number: 23DBP818; 184) DYNJ0347372G, UDI-DI: 10195327266028(each), 40195327266029(case), Lot Number: 22KBU586; 185) DYNJ0347372I, UDI-DI: 10195327418335(each), 40195327418336(case), Lot Number: 23IBK088; 186) DYNJ0347372I, UDI-DI: 10195327418335(each), 40195327418336(case), Lot Number: 23GBO695; 187) DYNJ28252G, UDI-DI: 10198459088124(each), 40198459088125(case), Lot Number: 25CBC137; 188) DYNJ28252G, UDI-DI: 10198459088124(each), 40198459088125(case), Lot Number: 25BBP572; 189) DYNJ30005G, UDI-DI: 10193489601794(each), 40193489601795(case), Lot Number: 21DMA051; 190) DYNJ32706B, UDI-DI: 10195327364304(each), 40195327364305(case), Lot Number: 23EMB628; 191) DYNJ38844N, UDI-DI: 10195327243166(each), 40195327243167(case), Lot Number: 23HBI619; 192) DYNJ38844N, UDI-DI: 10195327243166(each), 40195327243167(case), Lot Number: 23DBI585; 193) DYNJ47550C, UDI-DI: 10195327209964(each), 40195327209965(case), Lot Number: 23DBD093; 194) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 25KBF492; 195) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 24FBG329; 196) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 24CBQ847; 197) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23HBO785; 198) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23FBU806; 199) DYNJ47714A, UDI-DI: 10193489648867(each), 40193489648868(case), Lot Number: 23FBH830; 200) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 23CMB495; 201) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22KMH193; 202) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22HMC351; 203) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22HMA973; 204) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22EMA211; 205) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 22BMH522; 206) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21KMG274; 207) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21JMH124; 208) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21JMF391; 209) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21GMD682; 210) DYNJ49191B, UDI-DI: 10193489497489(each), 40193489497480(case), Lot Number: 21AMA809; 211) DYNJ49705K, UDI-DI: 10195327020347(each), 40195327020348(case), Lot Number: 22IMI306; 212) DYNJ50348F, UDI-DI: 10195327406349(each), 40195327406340(case), Lot Number: 23IMD230; 213) DYNJ50439F, UDI-DI: 10193489704921(each), 40193489704922(case), Lot Number: 22EBC737; 214) DYNJ51795F, UDI-DI: 10193489475937(each), 40193489475938(case), Lot Number: 21ADA184; 215) DYNJ51795F, UDI-DI: 10193489475937(each), 40193489475938(case), Lot Number: 20LDC148; 216) DYNJ52569B, UDI-DI: 10193489685190(each), 40193489685191(case), Lot Number: 23EBS784; 217) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 23BBA462; 218) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22LBD784; 219) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22HBV228; 220) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22GBJ776; 221) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 22ABC476; 222) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21JBR818; 223) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21IBG462; 224) DYNJ55862, UDI-DI: 10889942583997(each), 40889942583998(case), Lot Number: 21CBU815; 225) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21GME150; 226) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21FMB889; 227) DYNJ57607A, UDI-DI: 10193489206678(each), 40193489206679(case), Lot Number: 21EMB589; 228) DYNJ58321A, UDI-DI: 10193489489316(each), 40193489489317(case), Lot Number: 22ABG197; 229) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 22AME373; 230) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21JMF224; 231) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21HMD002; 232) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21EMF383; 233) DYNJ63079B, UDI-DI: 10193489425536(each), 40193489425537(case), Lot Number: 21DMB839; 234) DYNJ63079C, UDI-DI: 10195327102180(each), 40195327102181(case), Lot Number: 23GMB716; 235) DYNJ63079C, UDI-DI: 10195327102180(each), 40195327102181(case), Lot Number: 23EMI624; 236) DYNJ63079D, UDI-DI: 10195327505677(each), 40195327505678(case), Lot Number: 24BME368; 237) DYNJ63079D, UDI-DI: 10195327505677(each), 40195327505678(case), Lot Number: 23JMB435; 238) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25JMK630; 239) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25JMH582; 240) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 25AMH256; 241) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24JMD681; 242) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24HMH481; 243) DYNJ63079F, UDI-DI: 10198459043642(each), 40198459043643(case), Lot Number: 24HMC603; 244) DYNJ64266, UDI-DI: 10193489795516(each), 40193489795517(case), Lot Number: 21ADA447; 245) DYNJ66298D, UDI-DI: 10195327095895(each), 40195327095896(case), Lot Number: 23IBW233; 246) DYNJ67269, UDI-DI: 10193489394696(each), 40193489394697(case), Lot Number: 22KBG504; 247) DYNJ68710, UDI-DI: 10193489842906(each), 40193489842907(case), Lot Number: 22ABM641; 248) DYNJ69419A, UDI-DI: 10195327223588(each), 40195327223589(case), Lot Number: 23DBK434; 249) DYNJ69419A, UDI-DI: 10195327223588(each), 40195327223589(case), Lot Number: 23ABS144; 250) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24KMH362; 251) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24KME386; 252) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24GMG805; 253) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24GMC135; 254) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24EMD677; 255) DYNJ69419D, UDI-DI: 10195327688844(each), 40195327688845(case), Lot Number: 24EMC427; 256) DYNJ81492A, UDI-DI: 10195327348830(each), 40195327348831(case), Lot Number: 23BBT116; 257) DYNJ81761A, UDI-DI: 10195327574468(each), 40195327574469(case), Lot Number: 24FMF687; 258) DYNJ83475A, UDI-DI: 10195327460938(each), 40195327460939(case), Lot Number: 23HBY488; 259) DYNJ84783, UDI-DI: 10195327417949(each), 40195327417940(case), Lot Number: 23IBU517; 260) DYNJ86195A, UDI-DI: 10195327682286(each), 40195327682287(case), Lot Number: 24EBD237; 261) DYNJ900262A, UDI-DI: 10195327477820(each), 40195327477821(case), Lot Number: 23KBU736; 262) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 22JBR884; 263) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21KBP568; 264) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21KBF079; 265) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21JBV891; 266) DYNJ901133A, UDI-DI: 10888277949683(each), 40888277949684(case), Lot Number: 21JBM245; 267) DYNJ901559J, UDI-DI: 10193489235890(each), 40193489235891(case), Lot Number: 21EBR740; 268) DYNJ901559J, UDI-DI: 10193489235890(each), 40193489235891(case), Lot Number: 21CBH289; 269) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21FDB236; 270) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21BDA744; 271) DYNJ901812J, UDI-DI: 10193489814163(each), 40193489814164(case), Lot Number: 21ADB190; 272) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25GBR954; 273) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25EBK653; 274) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25DBB182; 275) DYNJ902711M, UDI-DI: 10198459229442(each), 40198459229443(case), Lot Number: 25ABS755; 276) DYNJ905066B, UDI-DI: 10195327098674(each), 40195327098675(case), Lot Number: 23BMF722; 277) DYNJ905066B, UDI-DI: 10195327098674(each), 40195327098675(case), Lot Number: 23BMB931; 278) DYNJ905269G, UDI-DI: 10193489337112(each), 40193489337113(case), Lot Number: 21BBD394; 279) DYNJ905269G, UDI-DI: 10193489337112(each), 40193489337113(case), Lot Number: 21ABH751; 280) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23FBE986; 281) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23EBQ671; 282) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 23DBT141; 283) DYNJ906322D, UDI-DI: 10193489969252(each), 40193489969253(case), Lot Number: 22GBL545; 284) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23FBP128; 285) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23DBM357; 286) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23BBB047; 287) DYNJ906452C, UDI-DI: 10195327228378(each), 40195327228379(case), Lot Number: 23BBA689; 288) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25IBI139; 289) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25HBO792; 290) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25GBB683; 291) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25EBA889; 292) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25BBO090; 293) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 25ABT788; 294) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24LBN196; 295) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24KBJ970; 296) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24IBN246; 297) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24HBM625; 298) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24FBJ836; 299) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24DBT181; 300) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24CBS248; 301) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24BBN302; 302) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 24ABD306; 303) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23LBJ184; 304) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23JBT789; 305) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23IBO509; 306) DYNJ906452D, UDI-DI: 10195327436636(each), 40195327436637(case), Lot Number: 23HBO123; 307) DYNJ906452F, UDI-DI: 10198459575303(each), 40198459575304(case), Lot Number: 25KBG657; 308) DYNJ906926B, UDI-DI: 10193489921366(each), 40193489921367(case), Lot Number: 23EBN137; 309) DYNJ907753F, UDI-DI: 10195327194482(each), 40195327194483(case), Lot Number: 22LBN185; 310) DYNJ907771C, UDI-DI: 10195327120399(each), 40195327120390(case), Lot Number: 22LBP170; 311) DYNJ908887B, UDI-DI: 10195327620158(each), 40195327620159(case), Lot Number: 24DBD796; 312) DYNJ908887B, UDI-DI: 10195327620158(each), 40195327620159(case), Lot Number: 24CBP744; 313) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24LBP187; 314) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24JBP902; 315) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24HBI648; 316) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24GBK492; 317) DYNJ908887C, UDI-DI: 10195327690793(each), 40195327690794(case), Lot Number: 24EBM187; 318) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23KME175; 319) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23JMB528; 320) DYNJ909398A, UDI-DI: 10195327338190(each), 40195327338191(case), Lot Number: 23HMI269; 321) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24HMA202; 322) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24DMI073; 323) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24CMI706; 324) DYNJ910009, UDI-DI: 10195327541149(each), 40195327541140(case), Lot Number: 24BMA251; 325) DYNJ910536, UDI-DI: 10198459029554(each), 40198459029555(case), Lot Number: 24GBA620; 326) DYNJ910536A, UDI-DI: 10198459054358(each), 40198459054359(case), Lot Number: 24IBE833; 327) DYNJ910589, UDI-DI: 10198459040894(each), 40198459040895(case), Lot Number: 24HBF839; 328) DYNJ910594, UDI-DI: 10198459041327(each), 40198459041328(case), Lot Number: 24HBF837; 329) DYNJ911567, UDI-DI: 10198459409004(each), 40198459409005(case), Lot Number: 25HBB593; 330) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21DMF113; 331) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21CKA812; 332) DYNJ9701096G, UDI-DI: 10193489779257(each), 40193489779258(case), Lot Number: 21CKA647; 333) DYNJ9701096I, UDI-DI: 10193489939651(each), 40193489939652(case), Lot Number: 22AMC654; 334) DYNJT3381, UDI-DI: 10198459325205(each), 40198459325206(case), Lot Number: 25EBK724
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.