Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIA...
FDA Device Recall #Z-1389-2026 — Class II — January 7, 2026
Recall Summary
| Recall Number | Z-1389-2026 |
| 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 | 30958 units |
Product Description
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE KIT, Model Number: DYNDA2076C; 6) CARDIAC CATH PACK-LF, Model Number: DYNJ0150605AC; 7) CATH LAB PACK-LF, Model Number: DYNJ0648473Y; 8) NBMC CATH PACK-LF, Model Number: DYNJ0803367I; 9) ANGIO PACK-LF, Model Number: DYNJ0954970I; 10) CARDIAC CATH PACK, Model Number: DYNJ19946M; 11) CATH LAB PACK, Model Number: DYNJ30955I; 12) CATH LAB PACK, Model Number: DYNJ31773K; 13) CATH PACK-LF, Model Number: DYNJ33061D; 14) DB CCL OAKWOOD PACK-LF, Model Number: DYNJ33620D; 15) CARDIAC CATH PACK MRH-LF, Model Number: DYNJ35300M; 16) CATH LAB PK, Model Number: DYNJ35643C; 17) CARDIAC CATH PACK-LF, Model Number: DYNJ39066B; 18) CATH PACK-LF, Model Number: DYNJ43101C; 19) OR ANGIO PACK-LF, Model Number: DYNJ43415D; 20) OR ANGIO PACK-LF, Model Number: DYNJ43415F; 21) ANGIOPLASTY PACK, Model Number: DYNJ44700J; 22) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 23) RADIOLOGICAL PACK, Model Number: DYNJ44889O; 24) CARDIAC CATH PACK, Model Number: DYNJ47370B; 25) ANGIOGRAPHY PACK, Model Number: DYNJ53129D; 26) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ56772G; 27) DR. MOHINDRA PACK, Model Number: DYNJ57602G; 28) NE ENDO VASCULAR PACK, Model Number: DYNJ57940B; 29) CARDIAC CATH PACK - Q1, Model Number: DYNJ58048C; 30) OR ANGIO, Model Number: DYNJ59931B; 31) LPCH PERRY CATH PACK, Model Number: DYNJ67378C; 32) HOSPITAL REGIONAL DE CONCEPCIO, Model Number: DYNJ67918A; 33) CATH LAB PACK, Model Number: DYNJ68633; 34) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197B; 35) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197C; 36) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197D; 37) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197F; 38) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197G; 39) BASIC CARDIAC CATH PACK, Model Number: DYNJ81593B; 40) UMC EL PASO CATH PACK, Model Number: DYNJ83089; 41) DR. MOHINDRA PACK, Model Number: DYNJ83819A; 42) VZ VAS/ANG PACK, Model Number: DYNJ83981; 43) WCPN CARDIOLOGY PACK, Model Number: DYNJ84539; 44) CATH LAB, Model Number: DYNJ85511; 45) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJT1520K; 46) ANGIOGRAPHY TRAY, Model Number: MNS9130; 47) CVC BUNDLE KIT, Model Number: ECVC6225A; 48) CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A
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) CDS985094F, UDI-DI: 10195327657642(each), 40195327657643(case), Lot Number: 25AMG933; 2) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 22ABO093; 3) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21LBJ748; 4) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21BBG516; 5) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21ABI976; 6) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 22ALA279; 7) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21KLA100; 8) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA930; 9) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25ALA014; 10) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24FLA816; 11) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24CLA777; 12) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23KLA402; 13) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23JLA979; 14) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23ILA268; 15) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23HLA316; 16) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA710; 17) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA176; 18) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23BLA583; 19) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 22HLB260; 20) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24LMB205; 21) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24KMC111; 22) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24HMD928; 23) DYNJ0150605AC, UDI-DI: 10198459106422(each), 40198459106423(case), Lot Number: 24IMB736; 24) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25EBR586; 25) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25CBO084; 26) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25BBT175; 27) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25ABH209; 28) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24LBE715; 29) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24IBS786; 30) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24HBQ060; 31) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24GBT979; 32) DYNJ0803367I, UDI-DI: 10195327461027(each), 40195327461028(case), Lot Number: 23IMC122; 33) DYNJ0954970I, UDI-DI: 10198459297571(each), 40198459297572(case), Lot Number: 25FMJ515; 34) DYNJ19946M, UDI-DI: 10193489907933(each), 40193489907934(case), Lot Number: 23HBO857; 35) DYNJ30955I, UDI-DI: 10195327428051(each), 40195327428052(case), Lot Number: 23GBN513; 36) DYNJ31773K, UDI-DI: 10195327245856(each), 40195327245857(case), Lot Number: 23ABB938; 37) DYNJ33061D, UDI-DI: 10193489841428(each), 40193489841429(case), Lot Number: 21CBI315; 38) DYNJ33620D, UDI-DI: 10889942677832(each), 40889942677833(case), Lot Number: 21ADA464; 39) DYNJ35300M, UDI-DI: 10195327101169(each), 40195327101160(case), Lot Number: 22JMB302; 40) DYNJ35643C, UDI-DI: 10195327111946(each), 40195327111947(case), Lot Number: 23CBI301; 41) DYNJ39066B, UDI-DI: 10193489937268(each), 40193489937269(case), Lot Number: 23HMG433; 42) DYNJ43101C, UDI-DI: 10888277737327(each), 40888277737328(case), Lot Number: 21ADA535; 43) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24CBG256; 44) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24ABI910; 45) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 23IBP533; 46) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 25EBF775; 47) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24LBQ306; 48) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24KBR090; 49) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24IBU874; 50) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24HBM254; 51) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24GBV382; 52) DYNJ44700J, UDI-DI: 10195327277413(each), 40195327277414(case), Lot Number: 25JDA679; 53) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23IBB504; 54) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23GBP204; 55) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23FBF258; 56) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23EBG893; 57) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23DBI845; 58) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23BBD736; 59) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23ABR589; 60) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22OBA581; 61) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22LBG760; 62) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBY064; 63) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBC588; 64) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22IBT510; 65) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22HBM547; 66) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22FBN577; 67) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22EBP030; 68) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22CBV346; 69) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABK883; 70) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABI539; 71) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 21KBO116; 72) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22CMA383; 73) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22AME756; 74) DYNJ47370B, UDI-DI: 10889942975723(each), 40889942975724(case), Lot Number: 22LBP706; 75) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23HMH791; 76) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23GMI002; 77) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23FME772; 78) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23EME724; 79) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23DMF448; 80) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23CMB279; 81) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23BMC700; 82) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22LMD047; 83) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22KMC442; 84) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22JME805; 85) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22IMG735; 86) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22GMI134; 87) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22CMH914; 88) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22BMG182; 89) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22AMD580; 90) DYNJ57602G, UDI-DI: 10195327338169(each), 40195327338160(case), Lot Number: 23BBK044; 91) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23KBB465; 92) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25KMD960; 93) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25JME465; 94) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25AMG240; 95) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24KMD474; 96) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24JMJ426; 97) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24HMF813; 98) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24GMH576; 99) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24EMH576; 100) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMG251; 101) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMC509; 102) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMG318; 103) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMF744; 104) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23LMD057; 105) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23KMH102; 106) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23IMD765; 107) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23GMF491; 108) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23FME284; 109) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23DMI350; 110) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23BME160; 111) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23AMI769; 112) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 22LMA967; 113) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23GBC772; 114) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23EBN753; 115) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23CBU118; 116) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23ABL095; 117) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22LBA917; 118) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22KBH299; 119) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22HBI355; 120) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22FBU003; 121) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBS611; 122) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBM388; 123) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22BBX590; 124) DYNJ67378C, UDI-DI: 10195327697501(each), 40195327697502(case), Lot Number: 24HME465; 125) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22OBG779; 126) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ027; 127) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ026; 128) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 21LBP804; 129) DYNJ68633, UDI-DI: 10193489837667(each), 40193489837668(case), Lot Number: 21BBQ520; 130) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23GBC445; 131) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23FBA862; 132) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBR165; 133) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBF780; 134) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23IBT017; 135) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23HBZ547; 136) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23GBJ036; 137) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24JBE696; 138) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24IBL386; 139) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24HBK118; 140) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24GBA095; 141) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24EBU925; 142) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24DBF346; 143) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24ABW070; 144) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25EBR556; 145) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25DBT193; 146) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25CBG703; 147) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 24LBU027; 148) DYNJ81197G, UDI-DI: 10198459369179(each), 40198459369170(case), Lot Number: 25FBT968; 149) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23IBJ841; 150) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23GBO156; 151) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23EBT723; 152) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23IMB693; 153) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23GMD133; 154) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23FMC409; 155) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23EMF492; 156) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMD375; 157) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMA913; 158) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23BMB766; 159) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 22JMI325; 160) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23HBX967; 161) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBV261; 162) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBJ743; 163) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23EBU525; 164) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23CBS129; 165) DYNJ83981, UDI-DI: 10195327324124(each), 40195327324125(case), Lot Number: 23CMI086; 166) DYNJ84539, UDI-DI: 10195327375706(each), 40195327375707(case), Lot Number: 23FMH066; 167) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25EBR907; 168) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24LBK715; 169) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24KBR659; 170) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24IBI836
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.