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 CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free 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 KNEE ARTHROSCOPY PACK 4 CUSTOMED 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 08 PAD PACK II 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 IV 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 1 (Ill) CUSTOMED 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 ARTHROSCOPY PACK I 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 - BIRTH PACK II {2) CUSTOMED CONTENT 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 EXTREMITY PACK {2) CUSTOMED CONTENT 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 CYSTOSCOPY PACK Ill 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 ABO 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 I 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 1 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 TRANSVERSE 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 LAPAROTOMY PACK Ill 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 EENT PACK I CUSTOMED CONTENT 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 ORTHOPEDIC PACK I 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 ORTHOPEDIC PACK Ill 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, 900-2510, package contains 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 Pack 900-2511, pack contains 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, 900-2516, pack contains: ( I) TABLE COVER44” X 90” ( I) CAUTERY PENCIL PUSH BOTTOM 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 Gown Cool Impervious XLGE Breathable Customed, 900-2592 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,900-2609, contains 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 Hip & Knee replacement pack, 900-2614, contains 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 Extremity Pack, code 900-2615, contains 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 Shoulder Pack, Code 900-2616, contains 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 Pack, code 900-2618, contains 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 Abdom w/pouch Customed code 900-2619, contains 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 HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (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 Universal Pack II 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 Shoulder pack (I) 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 Pack Customed, code 900-2582 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 Face Pack MRT 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 Liposuction Pack MRT, code 900-2656, contains 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 Tummy Pack MRT, code 900-2657, contains 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 Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc 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 Breast Implant Pack, Code 900-2660, contains 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 Tummy Tuck and Liposuction Pack, code 900-2661, contains: ( 1) DRAPE % ECONOMY 53 X 77 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 Liposuction Pack, code 900-2681, contains 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 Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682 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 Tummy Tuck Pack, code 900-2684, contains 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 Bandeja para Debridacion, code 900-2702, contains 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 Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH 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 Knee Arthroscopy Pack, code 900-2718, contains 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 Shoulder Arthroscopy Pack, code 900-2719, contains 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 Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains 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 REEMPLAZO DE RODILLA Y CADERA 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 MINOR PACK 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 SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23” X 1 7” (I) SCALPEL W/HANDLE # 15 S/STEEL… 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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