CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report
Medline Convenience Kits: Plastic Bin W/Misc Kits recalled
Medline Industries is recalling Medline Convenience Kits: Plastic Bin W/Misc Kits, distributed nationwide in the US. The recall was initiated on 7 Jan 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1397-2026
- FDA event ID
- 98329
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jan 2026
- FDA classified
- 17 Feb 2026
- Reported
- 25 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Breast Implants
Timeline
| 7 Jan 2026 | Recall initiated by company | |
| 17 Feb 2026 | Classified by FDA | +41 days |
| 25 Feb 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
35 other products · FDA event 98329This product is part of a recall event; the main page for the event is Medline Convenience Kits: Kit Surg Onc Excision Breast recalled.
More recalls from Medline Industries
All 705| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits containing Healthmark Instrument recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Neuro Vch recalled by Medline Industries | Medline Industries | Other | Nationwide |
Other Breast Implants recalls
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | Artoura Breast Tissue Expanders Reference Numbers recalled | Mentor Texas | Device Malfunction | Nationwide |
| Device | CLASS II | BBraun Medical Winged INF recalled | B Braun Medical | Device Malfunction | Nationwide |
| Device | CLASS II | B. Braun Winged Infusion, Single PK recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |