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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

3,505 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,505 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 3,505 FDA device recalls in MA.

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DateProductReasonClassFirm
Nov 7, 2020 NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product ... The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Class II Fresenius Medical Care Holdings, Inc.
Nov 7, 2020 NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Us... The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Class II Fresenius Medical Care Holdings, Inc.
Nov 7, 2020 NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product ... The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Class II Fresenius Medical Care Holdings, Inc.
Nov 7, 2020 NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product ... The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Class II Fresenius Medical Care Holdings, Inc.
Nov 7, 2020 NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Us... The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Class II Fresenius Medical Care Holdings, Inc.
Nov 7, 2020 NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product ... The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Class II Fresenius Medical Care Holdings, Inc.
Nov 7, 2020 NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Us... The sodium and/or calcium levels in these concentrates were below the manufacturing specifications. Class II Fresenius Medical Care Holdings, Inc.
Nov 3, 2020 EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascu... This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF... Class II Boston Scientific Corporation
Oct 19, 2020 MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage:... Treatment beam information disappears on Treatment Console screen while beam delivery continues p... Class II Mevion Medical Systems, Inc.
Oct 16, 2020 Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on pat... In-house lab observations and customer reports of overheating and/or thermal damage to the batter... Class II Covidien Llc
Sep 25, 2020 Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". ... Potential for the needle to detach from the cartridge after the bottom of the cartridge is twiste... Class II Cardinal Health 200, LLC
Sep 24, 2020 AMS 700 MS Pump with and without InhibiZone, sold as individual units and als... The recalling firm has observed an increase in complaints of problems encountered during the init... Class II Boston Scientific Corporation
Sep 22, 2020 Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MC... Incorrectly installed base. Class II Boston Scientific Corporation
Sep 22, 2020 Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product U... The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health 200, LLC
Sep 22, 2020 Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product ... The feeding spike sets may leak at the interface of the tube and spike connector. Class II Cardinal Health 200, LLC
Sep 21, 2020 iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Confor... Incorrect hip components were provided in kits. Class II Conformis, Inc.
Sep 21, 2020 5.5MM Arthrogarde Hip Access Cannula The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from ... Class II Smith & Nephew, Inc.
Sep 16, 2020 Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; ... RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. Class II Boston Scientific Corporation
Sep 14, 2020 Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Mode... The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator... Class II Philips North America, LLC
Sep 14, 2020 Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model ... The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator... Class II Philips North America, LLC
Sep 12, 2020 Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR18... The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked... Class II Fresenius Medical Care Holdings, Inc.
Sep 11, 2020 Synapse PACS Software Versions 5.1 and higher There is a potential for the wrong patient information may be displayed in the viewer or PowerJac... Class II Fujifilm Medical Systems U.S.A., Inc.
Sep 11, 2020 Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a we... FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D ... Class II Fujifilm Medical Systems U.S.A., Inc.
Sep 9, 2020 TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Nu... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 7... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Nu... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, 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.