Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY ...
FDA Device Recall #Z-1397-2026 — Class II — January 7, 2026
Recall Summary
| Recall Number | Z-1397-2026 |
| 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 | 4757 units |
Product Description
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 3) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 4) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182A; 9) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182B; 10) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183; 11) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183A; 12) KIT PLASTIC ROTATIONAL FLAP, Model Number: DYKMBNDL183B; 13) KIT STC FACIAL FRACTURE, Model Number: DYKMBNDL34A; 14) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39; 15) KIT SURG ONC MASTECTOMY A, Model Number: DYKMBNDL39A; 16) KIT SURG ONC MASTECTOMY, Model Number: DYKMBNDL39C; 17) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL46; 18) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54; 19) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69; 20) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69A; 21) KIT PLASTICS BREAST REDUCTION, Model Number: DYKMBNDL69B; 22) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78; 23) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78A; 24) KIT PLASTICS BREAST AUGMENTATI, Model Number: DYKMBNDL78B; 25) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84; 26) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84C; 27) MJR PLASTICS PK MV SURG CT-LF, Model Number: DYNJ0785310G; 28) ASC ENT PLASTIC PACK-LF, Model Number: DYNJ0854650J; 29) BREAST PACK ASC-LF, Model Number: DYNJ36469I; 30) ENT TYMPANOPLASTY PACK-LF, Model Number: DYNJ38988J; 31) DR WILDE BRSTMASS/PARTMAST-XM, Model Number: DYNJ39831F; 32) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852K; 33) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852M; 34) BREAST PACK, Model Number: DYNJ50957G; 35) PLASTICS BREAST PACK, Model Number: DYNJ55358G; 36) BHN IMPLANT PACK, Model Number: DYNJ56737A; 37) BREAST PACK, Model Number: DYNJ60210A; 38) PLASTICS PACK 2, Model Number: DYNJ64927F; 39) SPECIALTY FACIAL PLASTICS PACK, Model Number: DYNJ68844A; 40) BREAST IMPLANT PACK, Model Number: DYNJ69351; 41) BREAST/TUMMY PACK, Model Number: DYNJ83788; 42) HMSL PLASTICS, Model Number: DYNJ83884B; 43) CHEST/BREAST-LF, Model Number: DYNJ83950A; 44) CHEST/BREAST-LF, Model Number: DYNJ83950B; 45) FREE FLAP A DIRTY, Model Number: DYNJ86165; 46) MAJOR SURGERY PACK, Model Number: DYNJ86816; 47) BREAST REDUCTION PACK, Model Number: DYNJ87444; 48) OMF FREE FLAP, Model Number: DYNJ902005I; 49) BREAST CDS, Model Number: DYNJ902558G; 50) TRUNCAL CONTOURING, Model Number: DYNJ903555D; 51) TRUNCAL CONTOURING, Model Number: DYNJ903555F; 52) NEW TISSUE RETRIEVAL MH, Model Number: DYNJ903849C; 53) LARGE PROCEDURE-LF, Model Number: DYNJ907847A; 54) (34) STC FACIAL FRACTURE, Model Number: DYNJ907874A; 55) FACELIFT, Model Number: DYNJ910462; 56) MAJOR PLASTIC BREAST PACK-LF, Model Number: DYNJT3283; 57) MAJOR BREAST PACK-LF, Model Number: DYNJT3417; 58) PLASTICS PACK-LF, Model Number: PHS806973G
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) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDB702; 2) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25BDA228; 3) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 25ADB705; 4) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24JDA650; 5) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 24IDA403; 6) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23LDC086; 7) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23IDB182; 8) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 23HDB786; 9) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21JDB530; 10) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21HDB434; 11) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21GDB740; 12) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21FDA888; 13) ACC010499, UDI-DI: 10193489845709(each), 40193489845700(case), Lot Number: 21DDA661; 14) DYKMBNDL117C, UDI-DI: 10195327371104(each), 40195327371105(case), Lot Number: 23DLA834; 15) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21CBE548; 16) DYKMBNDL158, UDI-DI: 10193489478266(each), 40193489478267(case), Lot Number: 21ABI978; 17) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22IBC515; 18) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22HBN456; 19) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 22EBA143; 20) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21IBV640; 21) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21DBN049; 22) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21BBH637; 23) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 21ABJ202; 24) DYKMBNDL170, UDI-DI: 10193489477450(each), 40193489477451(case), Lot Number: 20LBY951; 25) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23IBB851; 26) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBG507; 27) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23HBB877; 28) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 23GBR888; 29) DYKMBNDL170A, UDI-DI: 10195327240813(each), 40195327240814(case), Lot Number: 22JBM366; 30) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25LBM160; 31) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25KBR870; 32) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25GBA895; 33) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25EBM448; 34) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBS731; 35) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25DBK034; 36) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBN216; 37) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 25BBA340; 38) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24IBB931; 39) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBL546; 40) DYKMBNDL170B, UDI-DI: 10195327633783(each), 40195327633784(case), Lot Number: 24FBD539; 41) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 23LBI220; 42) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22FBC879; 43) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22EBO665; 44) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 22BBN306; 45) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21DBC569; 46) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABX025; 47) DYKMBNDL182, UDI-DI: 10193489485370(each), 40193489485371(case), Lot Number: 21ABI990; 48) DYKMBNDL182A, UDI-DI: 10195327633806(each), 40195327633807(case), Lot Number: 24BBN507; 49) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25FBO935; 50) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 25ABL533; 51) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24KBS891; 52) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBQ469; 53) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24IBL678; 54) DYKMBNDL182B, UDI-DI: 10198459000478(each), 40198459000479(case), Lot Number: 24DBR913; 55) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21JBJ252; 56) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21CBG305; 57) DYKMBNDL183, UDI-DI: 10193489478495(each), 40193489478496(case), Lot Number: 21ABI992; 58) DYKMBNDL183A, UDI-DI: 10195327246594(each), 40195327246595(case), Lot Number: 23BBI487; 59) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24GBC829; 60) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBT970; 61) DYKMBNDL183B, UDI-DI: 10195327633813(each), 40195327633814(case), Lot Number: 24DBJ591; 62) DYKMBNDL34A, UDI-DI: 10193489872033(each), 40193489872034(case), Lot Number: 21DBQ512; 63) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22IBC434; 64) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22GBM861; 65) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 22BBU074; 66) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21LBJ742; 67) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21GBR352; 68) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21CBD335; 69) DYKMBNDL39, UDI-DI: 10193489477764(each), 40193489477765(case), Lot Number: 21ABJ002; 70) DYKMBNDL39A, UDI-DI: 10195327241308(each), 40195327241309(case), Lot Number: 23ABH677; 71) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 25GBW751; 72) DYKMBNDL39C, UDI-DI: 10198459112461(each), 40198459112462(case), Lot Number: 24JBO020; 73) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21GBR353; 74) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21BBM839; 75) DYKMBNDL46, UDI-DI: 10193489478761(each), 40193489478762(case), Lot Number: 21ABL308; 76) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21CBG791; 77) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21BBH629; 78) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABO607; 79) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABM089; 80) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 21ABJ589; 81) DYKMBNDL54, UDI-DI: 10193489478822(each), 40193489478823(case), Lot Number: 20LBY967; 82) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22JBC409; 83) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22IBR235; 84) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBQ100; 85) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 22HBN457; 86) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21JBS176; 87) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21IBV702; 88) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBO272; 89) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBM983; 90) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21HBK340; 91) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21GBR324; 92) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21DBC571; 93) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABL345; 94) DYKMBNDL69, UDI-DI: 10193489477726(each), 40193489477727(case), Lot Number: 21ABJ013; 95) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23LBA275; 96) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23JBJ695; 97) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23GBL960; 98) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 23FBP246; 99) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22KBO876; 100) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBQ852; 101) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBJ150; 102) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC626; 103) DYKMBNDL69A, UDI-DI: 10195327241155(each), 40195327241156(case), Lot Number: 22JBC618; 104) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25KBP763; 105) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25GBL984; 106) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 25FBH462; 107) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24KBT018; 108) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24HBM099; 109) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24GBF481; 110) DYKMBNDL69B, UDI-DI: 10195327633653(each), 40195327633654(case), Lot Number: 24EBR715; 111) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22EBS816; 112) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22CBX537; 113) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22BBL848; 114) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABL251; 115) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 22ABG018; 116) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBY278; 117) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21LBO572; 118) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21KBY757; 119) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21JBJ751; 120) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBV643; 121) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21IBB097; 122) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21HBK310; 123) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBR398; 124) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21FBF907; 125) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21DBC549; 126) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21BBK531; 127) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABX017; 128) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 21ABJ216; 129) DYKMBNDL78, UDI-DI: 10193489478044(each), 40193489478045(case), Lot Number: 20XBB257; 130) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23LBE774; 131) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23JBN862; 132) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBP831; 133) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 23GBO451; 134) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22KBO921; 135) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBQ856; 136) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ143; 137) DYKMBNDL78A, UDI-DI: 10195327241179(each), 40195327241170(case), Lot Number: 22JBJ019; 138) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25FBP527; 139) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBM007; 140) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25EBE325; 141) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25CBG915; 142) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBU089; 143) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBO685; 144) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 25BBE752; 145) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24LBL035; 146) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24HBD157; 147) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBU597; 148) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24EBE953; 149) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBR114; 150) DYKMBNDL78B, UDI-DI: 10195327633684(each), 40195327633685(case), Lot Number: 24CBF892; 151) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22OBH455; 152) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22IBC435; 153) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22HBO907; 154) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBT013; 155) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 22FBF307; 156) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBH705; 157) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21LBD628; 158) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21JBH111; 159) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21IBT011; 160) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21GBR338; 161) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21GBF538; 162) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21EBH614; 163) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21CBM835; 164) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21ABU822; 165) DYKMBNDL84, UDI-DI: 10193489477801(each), 40193489477802(case), Lot Number: 21ABM088; 166) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25LBQ326; 167) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25LBP864; 168) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25HBG553; 169) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25GBF486; 170) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25FBB154; 171) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 25DBO560; 172) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24LBS883; 173) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24LBI135; 174) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24JBE336; 175) DYKMBNDL84C, UDI-DI: 10198459112454(each), 40198459112455(case), Lot Number: 24IBE175; 176) DYNJ0785310G, UDI-DI: 10193489268966(each), 40193489268967(case), Lot Number: 23KMH075; 177) DYNJ0854650J, UDI-DI: 10193489832426(each), 40193489832427(case), Lot Number: 24IMF274; 178) DYNJ36469I, UDI-DI: 10195327513931(each), 40195327513932(case), Lot Number: 24BBU341; 179) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21CDB475; 180) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21BDB779; 181) DYNJ38988J, UDI-DI: 10193489315233(each), 40193489315234(case), Lot Number: 21ADA533; 182) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24KMD041; 183) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24IME867; 184) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24GMA471; 185) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24DMJ046; 186) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24CMD088; 187) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 24AMI035; 188) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23LMB124; 189) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23KMA468; 190) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23IMG016; 191) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23HMA900; 192) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 23AME665; 193) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22IMF713; 194) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22HMH034; 195) DYNJ39831F, UDI-DI: 10195327176396(each), 40195327176397(case), Lot Number: 22GMF684; 196) DYNJ44852K, UDI-DI: 10195327127589(each), 40195327127580(case), Lot Number: 22CMI118; 197) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 25EME929; 198) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 25CME690; 199) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24KME600; 200) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24GMI186; 201) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24CMC758; 202) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 24AMB315; 203) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23HME689; 204) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23FMH424; 205) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23DMD096; 206) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23CMF343; 207) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23AMC530; 208) DYNJ44852M, UDI-DI: 10195327325220(each), 40195327325221(case), Lot Number: 23AMC374; 209) DYNJ50957G, UDI-DI: 10193489448863(each), 40193489448864(case), Lot Number: 23GBV065; 210) DYNJ55358G, UDI-DI: 10195327173500(each), 40195327173501(case), Lot Number: 23FBN323; 211) DYNJ56737A, UDI-DI: 10193489395594(each), 40193489395595(case), Lot Number: 23CME388; 212) DYNJ60210A, UDI-DI: 10193489985108(each), 40193489985109(case), Lot Number: 21KBP457; 213) DYNJ64927F, UDI-DI: 10195327143091(each), 40195327143092(case), Lot Number: 23FBV335; 214) DYNJ68844A, UDI-DI: 10195327216504(each), 40195327216505(case), Lot Number: 23HMB858; 215) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 24BBL537; 216) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23KBN973; 217) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23JBU455; 218) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23HBY228; 219) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23CBG820; 220) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23BBP453; 221) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 23BBD661; 222) DYNJ69351, UDI-DI: 10193489934212(each), 40193489934213(case), Lot Number: 21LBP376; 223) DYNJ83788, UDI-DI: 10195327305833(each), 40195327305834(case), Lot Number: 23CBO212; 224) DYNJ83884B, UDI-DI: 10198459234620(each), 40198459234621(case), Lot Number: 25GBO120; 225) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 25ABF915; 226) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24JBV233; 227) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24FBL440; 228) DYNJ83950A, UDI-DI: 10198459018510(each), 40198459018511(case), Lot Number: 24EBR736; 229) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25DBT195; 230) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25CBF253; 231) DYNJ83950B, UDI-DI: 10198459257827(each), 40198459257828(case), Lot Number: 25ABT952; 232) DYNJ86165, UDI-DI: 10195327599324(each), 40195327599325(case), Lot Number: 25ABJ747; 233) DYNJ86816, UDI-DI: 10195327679903(each), 40195327679904(case), Lot Number: 24FMB609; 234) DYNJ87444, UDI-DI: 10198459040122(each), 40198459040123(case), Lot Number: 24GBQ988; 235) DYNJ902005I, UDI-DI: 10195327347710(each), 40195327347711(case), Lot Number: 24DLA844; 236) DYNJ902558G, UDI-DI: 10193489728859(each), 40193489728850(case), Lot Number: 23HMG989; 237) DYNJ903555D, UDI-DI: 10195327084615(each), 40195327084616(case), Lot Number: 22HBF672; 238) DYNJ903555D, UDI-DI: 10195327084615(each), 40195327084616(case), Lot Number: 22GBT713; 239) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBP519; 240) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBP518; 241) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23GBG876; 242) DYNJ903555F, UDI-DI: 10195327224585(each), 40195327224586(case), Lot Number: 23FBN475; 243) DYNJ903849C, UDI-DI: 10195327333355(each), 40195327333356(case), Lot Number: 23DBS608; 244) DYNJ907847A, UDI-DI: 10193489937589(each), 40193489937580(case), Lot Number: 23IMF989; 245) DYNJ907874A, UDI-DI: 10195327241247(each), 40195327241248(case), Lot Number: 23FLA249; 246) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24JMD608; 247) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24IMF741; 248) DYNJ910462, UDI-DI: 10195327695637(each), 40195327695638(case), Lot Number: 24GME383; 249) DYNJT3283, UDI-DI: 10198459323645(each), 40198459323646(case), Lot Number: 25JBI499; 250) DYNJT3417, UDI-DI: 10198459324888(each), 40198459324889(case), Lot Number: 25EBN203; 251) PHS806973G, UDI-DI: 10193489926996(each), 40193489926997(case), Lot Number: 23EBQ702
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.