Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Hernia Pack, Kit number AMS1519 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Hystero Pack, Kit number PSS3535 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Laparoscopic Pack, Kit number AMS2499 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Laparotomy Pack, Kit number 006047-2, 006268-8, 006268-9, AMS4418, PSS2154, PSS2190, and PSS2190(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Laparotomy Tray, Kit number PSS1538 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Lipo Pack, Kit number AMS4420 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669 The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Major Laparotomy Pack - NS, kit number AMS4347 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Major Lithotomy Pack, kit number 002641-5 and 002641-6 convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Major Pack, Kit Number PSS3516 and PSS3516(A convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B convenience custom kits used for… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Newport Coast Basic Pack, Kit number 007484-1 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall OB/GYN Pack, Kit number AMS2038 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Ocular Plastic Pack, Kit number AMS3868 and AMS3868(A convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Ortho Minor Pack, Kit number AMS3710 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
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FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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