Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Wound Management Tray Ill Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Utility Drape End Product Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Incision & Drainage Tray Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Skin Staple Removal Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Wound Management Tray Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Wound Management Tray II Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Gown Surgical Non Reinforced XL Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Wound Management Tray Ryder Memorial Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Leggings W/7’’ Cuff Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Minor Laceration Tray Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Mayo Stand Cover W/CSR Wrap Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Wound Management Tray Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Gown Surg Fully Impervious Large Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Gown Surgical Poly Reinforced XL X-Long Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Gown Surgical Non Reinforced XXL Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Gown Fabric Reinforced XXL Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Gown Surgical Fabric Reinforced XL Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Gown Surgical Fabic Reinforced Large Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Angiodrape Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound… Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Laparoscopy Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Major Laparotomy Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Cysto Tur Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound… Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Arthroscopy Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Laparoscopy Chole Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Peri Gyn Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Arthroscopy Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Peri Gyn Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Foley Catheter Kit Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Foley Catheter Kit Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Neuro Pack, Catalog number 900-1146. Used by medical staff to perform patient care procedures such as wound… Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Laparoscopy Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Laparoscopy OB GYN Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Open Heart Tray Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Laminectomy Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Premium Cesarean Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Premium Laparotomy Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Premium OB Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Neuro Spine Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Pediatric Lap Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Open Heart Tray Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Plastic Surgery Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Umbilical Vessel Catheter Kit Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Cirugia Cardiovascular Case Cart Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall Reyito Urological Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall D&C Laparoscopy Pack Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
- Medical device recall ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound… Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 10, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 10, 2014ClassClass IStatusTerminatedWhereFlorida, New York and Puerto Rico
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
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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