Drape, Surgical, Exempt

Reports per year

Source: FDA adverse event reports by year received, 2018–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-05-07Open, ClassifiedProcess control

  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

  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.

• 2026-03-12Open, ClassifiedLabeling Change Control

  Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTDXUNDBGN DBD-DRAPE,UNDERBUTTOCK,28 X 50.5,XALT GR MDTMAYOXGN DBD-DRAPE,COVER,MAYO STAND,RESISTAT/XALT MDTZ1003656GN DBD-POCKET SHEET,RESISTAT/XALT

  Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.

• 2026-02-17Open, ClassifiedUnder Investigation by firm

  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

  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.

• 2025-06-12Open, ClassifiedLabeling Change Control

  Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.

  Due to non-sterile products being labeled as sterile

• 2025-03-14Open, ClassifiedPackaging process control

  Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRAPE,FEMORAL,RADIAL,5/CS; DRAPE,C-SECTION,FEN,CLR SCREEN,WIRE,7/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,HAND,ULTRAGARD,18/CS; DRAPE,U,ORTHOMAX,6/CS; DRAPE,SPLIT,77X120",10/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS; DRAPE,ROBOTIC,W/LEGGING,W/POUCH,5/CS. Sterile surgical drape.

  Potential breach in pouch packaging which could lead to loss of sterility.

• 2023-07-28Open, ClassifiedUnder Investigation by firm

  Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 127 cm (50 in), Model 60050S, pkgd. 25/case, sterile; (4) Ecolab Genesys Equipment Drape, Universal X-Ray Equipment Drape, 104 cm x 318 cm, Model 890017, pkgd. 6/case, sterile; and (5) Ecolab Genesys Microtek C-Arm / Mobile X-Ray Drape, 104 cm x 188 cm (41 in x 74 in), Model 4951N, pkgd. 50/case, sterile.

  Certain lots of the products have a Naphthalene odor.

• 2022-11-18Open, ClassifiedComponent change control

  3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape

  During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

• 2022-11-18Open, ClassifiedComponent change control

  3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape

  During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

• 2022-11-18Open, ClassifiedComponent change control

  3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape

  During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

• 2022-11-18Open, ClassifiedComponent change control

  3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape

  During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.