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 Laparoscopy and 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 Laparotomy Pack 1 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 Transverse Laparotomy 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 Laparotomy 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
- Medical device recall Urology 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 Minor Pack, catalog #900-2511 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 Laparotomy 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 OB Pack, catalog #900-254 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 Gown Cool Impervious XLGE Breathable 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 Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such… 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 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 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 Open Heart 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 Liposuction 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 Tummy Tuck & 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 Bandeja para Debridacion (Debridement Tray) 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 Reemplazo de Rodilla y Cadera Knee and Hip Replacement tray 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 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 Laparotomy 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 Laparotomy 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 Orthopedic 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 Cysto Tur 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 ACDF Pack, catalog #900-2917 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 Transforaminal Lumbar Interbody Fusion (TLIF) 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 Hair Restoration 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 Tummy Tuck 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 Liposuction 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 Breast Pack Used by medical staff to perform patient care procedures such as wound healing, suture removals,… 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 Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound… 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 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 Gown Impervious Extra Long X-Large with Towel & Wrap 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 Breat Pack-TPSC 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 W/Out Gown 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 Cesarean 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 Major Lap 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 Cesarean 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 Laparoscopy Chole 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 Labor & Delivery 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 Cysto Tur 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 Minor Laparotomy 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 Laparoscopy 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 Laparoscopy 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 Laparoscopy 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 Laparotomy Basic 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 Pery GYN 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 Laparoscopy Cholecystectomy 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 Laparoscopy Gyn 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
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.”
Your shortlist0 of 4
Add one more to compare.