Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 4, 2014 | Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unic... | Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... | Class II | Blue Belt Technologies MN |
| May 30, 2014 | Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoa... | Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family o... | Class III | Alere San Diego, Inc. |
| May 29, 2014 | Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius ... | The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found... | Class II | Synthes, Inc. |
| May 28, 2014 | Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculati... | Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1,... | Class II | Baxter Corporation Englewood |
| May 23, 2014 | RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Me... | Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the ... | Class II | Teleflex Medical |
| May 21, 2014 | cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filt... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filt... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catal... | A portion of the BBL Crystal Enteric/Nonfermentor (E/NF) Identification kits from lot numbers 322... | Class III | Becton Dickinson & Co. |
| May 20, 2014 | FEMORAL ANGIOGRAPHY PACK - (1) TABLE COVER REINFORCED 50" X 90" UF (1) GOW... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Customed Major Laparotomy Pack , convenience pack include multiple components... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN S... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABS... | 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- (25) SPONGE LAP PREWASH 18" X 18" XRD L/F (1) T... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | NEURO PACK - (1) CAUTERY TIP POLISHER LIF (4) DRAPE UTILITY WITH TAPE LIF ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE W... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH L... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) ... | 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 UF (1) UNDERBUTTOCK DRAPE WIT... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF (1 0) GAUZE SPONGE ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X ... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY OB GYN PACK - (1) DURAPREP SURGICAL SOLUTION 26ML LIF (1) SHEE... | 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) STRIP STERI CLOSURE W' X 4" LIF ( 1) TABLE... | 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.