Browse Device Recalls
682 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 682 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 682 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 20, 2014 | Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LIPOSUCTION PACK AESTHETIC SURG.CENTER CONTENTS: (1) BLADE SURG. #11 CARB... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | BASIC PACK IV (6) CUSTOMED CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1)... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROTOMY PACK 1 (2&3) CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 2... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREA... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | CESAREAN PACK - (1) MAYO STAND COVER REINFORCED LIF (5) TOWELS ABSORBENT L... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Plastic Pack Customed, code 900-2582 (1) GOWN LGE SMS IMP REINF L/F (1) GO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) A... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE U... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Lithotomy Pack III (3), code 900-2487, contains: (3) TOWEL ABSORBENT 15" X 2... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16o... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCE... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY COLORECTAL SURGICAL PACK CONTENTS: (1) SOLUTION SURGICAL D... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | PERl GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (2) TOWELS ABSORBENT 15" X ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Open Heart Tray, Pack A, code 900-1196C, contains: (1) TABLE COVER REINFORCE... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SU... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Obstetrical Surgical pack, code 900-2940, contains: (1) BLANKET RECEIVING ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAN... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SH... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Basic Pack FPSC Florham Pack , code 900-2969, contains: (1) COVER TABLE REIN... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | UROLOGY PACK- (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECT Y.... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POU... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONN... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SM... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | C-SECTION PACK - (1) TABLE COVER REINFORCED 50" X 90" L/F (3) TOWELS ABSOR... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS R... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELAS... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Customed Cysto Tur Pack, convenience pack include multiple components: leggin... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/N... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | D & C LAPAROSCOPY PACK - (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT (1)... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | VEIN PACK - (1) GOWN STANDARD LARGE SMS VELCRO/NECK (3) LAP. SPONGES PREWA... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | MINOR LAPAROTOMY PACK - (1) DRAPE T LAPAROTOMY (1) BAG SUTURE FLORAL LIF (... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | UROLOGY PACK- (2) SYRINGE 30ML SLIP TIP 1 ML LIF (2) GOWN SURG. REINFORCED... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY CHOLECYSTECTOMY SURGICAL PACK - - (1) DRAPE LAPAROS/ABDOMIN... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORC... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY CHOLE PACK - (1) DRAPE LASER CAMERA WITH ELASTIC 6" X 96" LIF ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.