Medline Industries, LP: 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

Recall number

Z-1397-2026

Recalling firm

Medline Industries, LP

Product

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

Status

Open, Classified

Initiated

2026-01-07

Posted

2026-02-17

Terminated

not on file

Reason

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.

Root cause

Under Investigation by firm

Action

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-003 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form,

Quantity

4757 units

Distribution

Worldwide distribution - US Nationwide.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

FTN

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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