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 CATARACT PACK- OJOS INC. 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 STRABISMUS & PLASTIC 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 ARHTROSCOPY 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 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 PERl 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 C-SECTION 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 OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50” X 90” LIF (2) LEGGINS… 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 LAPAROSCOPY CHOLE 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 PERl 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 PERY GYN 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 FOLEY CATHETER KIT 1116FR. - CUSTOM ED 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 FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS 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 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 PHACO 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 LAP AROSCOPY 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 OB 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 LAMINECTOMY PACK - ( I) RING BASIN 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 OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4” X 4” 12PL Y (2) LEGGINS W/ 7” CUFF (2) DRAPE SHEET SMS… 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 PREMIUM OPHTHALMIC 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 PREMIUM CESAREAN 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 PREMIUM UROLOGY 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 PREMIUM LAPAROTOMY 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 PREMIUM O.B. PACK - CUSTOMED- (1) TABLE COVER REINFORCED 50” X 90” LIF (10) GAUZE SPONGES 4” X 4” 12PLY 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 PREMIUM ARTHROSCOPY 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 NEURO SPINE 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 PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102” X 121” X 78” ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE… 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 OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS 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 VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWASH XRD LIF (1) EXTREMITY SHEET ABS… 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 - LABEL SAMPLE CONTENTS 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 UMBILICAL VESSEL CATHETER 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 REYITO 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 IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT… 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 E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50” X 90” LIF (1) MAYO STAND COVER… 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 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 D & C 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 CIRUGIA CARDIOVASCULAR - CASE CART 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 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 DRESSING CHANGE - 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 UNIVERSAL 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 RETINA 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 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 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 O.B. PACK - (I) TABLE COVER REINFORCED 50” X 90” LIF (I) DRAPE UNDERBUTTOCK WITH POUCH 44” X 35” (2) LEGGINS… 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
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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