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 has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall 0.B. PACK - HSCH- (1) PVP SCRUB 8” STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7” CUFF… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROTOMY PACK - (I) SURGICAL BLADE #10 S/STEEL ( I) UTILITY BOWL 32oz (I) UTILITY BOWL 16oz Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall BASIC PACK W/OUT GOWN Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall OPHTALMIC PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ANGIODRAPE PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CESAREAN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall MAJOR LAP PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CESAREAN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY CHOLE PACK - - ( 1) STRIP STERI CLOSURE W’ X 4” LIF ( 1) TABLE COVER REINFORCED 50” X 90” LIF (… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LABOR & DELIVERY PAC - 1) NEEDLE HYPODERMIC 18G X 1% ST. Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CYSTO TUR PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall MINOR LAPAROTOMY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY~OBPACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROTOMY BASIC PACK- CUSTOMED Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall PERY GYN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall PERY GYN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY CHOLECYSTECTOMY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY GYN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROSCOPY GYN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ARTHROSCOPY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20” X 20 EO sterilized surgical convenient… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall FANFOLD DRAPE - CUSTOMED Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall PERY GYN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall 0.B. PACK - - (1) TABLE COVER 44” x 90” (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7” CUFF 30” x 42”… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CESAREAN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ARTHROSCOPY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ARTHROSCOPY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ORTHO IMPLANT SURGICAL PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CARPALTUNNELLARGE Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CARPAL TUNNEL SURGICAL LARGE PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall NEURO PACK- (1)TABLE COVER 44” x 90” (1) GOWN SURGEON REINFORCED X-LARGE TIWRAP (1) GOWN IMPERVIOUS… Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall GENERAL MINOR PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall FEMORAL ANGIOGRAPHY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CESAREAN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall UROLOGY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall ARTHROSCOPY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CURATION KIT - CUSTOMED Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall PLASTIC SURGERY PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall CESAREAN PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
- Medical device recall C-SECTION SURGICAL PACK Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 10, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 10, 2014ClassClass IStatusTerminatedWhereNationwide, and Florida, Puerto Rico and US Virgin Islands named
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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