FDAFDA · Food and drugs·Recall number Z-2128-2026

Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903

Published May 13, 2026 · Recall initiated: January 7, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Medline Industries, LP
Distributor: Worldwide - US Nationwide distribution.
Lot: 1) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30525050127; 2) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30525070161; 3) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30525070250; 4) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30525060147; 5) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522030151; 6) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522070033; 7) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522080015; 8) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522080067; 9) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522090028; 10) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522100060; 11) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522100091; 12) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522120121; 13) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30522120207; 14) DYNJP2410, UDI-DI: 10080196739691(each), 40080196739692(case), Lot Number: 30523010081; 15) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525030122; 16) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525050190; 17) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525040163; 18) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525060157; 19) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30525080250; 20) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523010024; 21) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523010087; 22) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523020008; 23) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523030039; 24) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523110089; 25) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30523120129; 26) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524020157; 27) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524020226; 28) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524030047; 29) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524040134; 30) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524050261; 31) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524060216; 32) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524080030; 33) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524100145; 34) DYNJP2411, UDI-DI: 10080196745487(each), 40080196745488(case), Lot Number: 30524120085; 35) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525050185; 36) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525070162; 37) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525070251; 38) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525060148; 39) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30525080246; 40) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 30522060085; 41) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 72524020098; 42) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 72524030048; 43) DYNJP2412, UDI-DI: 10080196739684(each), 40080196739685(case), Lot Number: 72524030074; 44) DYNJP2412, UDI-DI: 10080196739684(each), 40080196
Risk classification: Class II
Area (FDA): device
Country: United States

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