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 |
|---|---|---|---|---|
| May 20, 2014 | EAR PACK CONTENTS: (I) CAUTERY PENC IL ROCKER SW I TI-I CH ( I ) EMES... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1... | 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 ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLA... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TI... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMII... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY CHOLE SYSTEM PACK MIAMI METRO CON TENTS: (12) TOWELS CLO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF (... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I)... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS RE... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ARTHROSCOPY PACK - (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) ESMARK BAND... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER T... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | DRESSING CHANGE - CUSTOMED- (2) GLOVE MED. FREETOUCH VYNIL POWDER FREE ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL S... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN S... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | KNEE ARTHROSCOPY PACK CONTENTS: (1) TOWEL ABSORBENT 15" X 20" L/F (1... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Liposuction Pack, code 900-2681, 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 | TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURG... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARG... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | PREMIUM UROLOGY PACK - CUSTOMED- (1) LITHOTOMY DRAPE W/POUCH ANESTH. (2)... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | CERVICAL PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI ... | 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) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS RE... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDP... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1)... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOW... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Laparoscopy pack, , Code 900-3178, contains: (1) BULB SYRINGE 60cc LIF (10)... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Customed Femoral Pack , convenience pack include multiple components: Syringe... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAF... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REI... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 ... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICA... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 20, 2014 | FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TR... | 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 code 900-2259A, contains: (1) SOLUTIO... | Customed has determined that there is the possibility that packaging integrity may be compromised... | Class I | Customed, Inc |
| May 16, 2014 | GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoa... | Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in ... | Class II | Nidek 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.