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 Angiography 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 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 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 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 Urology 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 Dressing Change 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 Universal 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 Retina Pack, Catalog number 900-1611. 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 Femoral 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 Labor & Delivery 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 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 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 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 OB Pack, Catalog number 900-1717. 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 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 Minor 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 Urology 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 Urology 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 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 Ophtalmic 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 Premium 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 Hip Orthopedia 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 Ophtalmic 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 Universal 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 Endovenous Custom 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 Higado & Pancrea 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 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 Orthopedic 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 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 Angiography 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 Angiography Pack Significant 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 Knee Arthroscopy Pack Significant 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 Femoral Pack Significant 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 Lithotomy Pack Significant 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 Shoulder Arthroscopy Pack Significant 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 Surgical Pack Significant 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 Ear Pack, catalog #900-2234 Used by medical staff to perform patient care procedures such as wound healing,… Significant 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 #900-2256 Used by medical staff to perform patient care procedures such as wound healing,… Significant 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 Colorectal Surgical Pack Significant 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 General Line Full Body Drape Significant 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 Vaginal Procedure Pack Significant 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 Total Hysterectomy Significant 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 Extremity Arm Pack Significant 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 Basic Pack 1 (III) Significant 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 Significant 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 Cystoscopy Pack III Significant 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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