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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

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
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.
Sep 9, 2020 TWINFIX ULTRA HA 5.5 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 ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-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 OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-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 TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 721... 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 / 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 ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors 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 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 OSTEORAPTOR CRVD 2.3 SA UB COBRD 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 OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 7220... 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 5.5MM 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 TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO 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 5.0MM AB SUTURE ANCHOR WITH TWO- 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 OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 1, 2020 AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodia... Incorrectly crimped connectors were installed on the main protective earth conductor on these mac... Class II Fresenius Medical Care Holdings, Inc.
Aug 28, 2020 Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative t... Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potentia... Class II Siemens Healthcare Diagnostics Inc
Aug 25, 2020 Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI... Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IF... Class II Siemens Healthcare Diagnostics, Inc
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Singl... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
Aug 25, 2020 Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, ... Subsequent failure of catheters in the field and failed quality testing Class I Medtronic Vascular
Aug 24, 2020 Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expirat... Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping le... Class II Boston Scientific Corporation
Aug 7, 2020 WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M... Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Bil... Class II Boston Scientific Corporation
Jul 24, 2020 Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barrica... The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner co... Class II Intrinsic Therapeutics, Inc.
Jul 20, 2020 Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic ... Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0... Class II Conformis, Inc.
Jul 16, 2020 Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M35... The therapy switch may fail, resulting in the device exhibiting the following behaviors: the devi... Class II Philips North America, LLC
Jul 15, 2020 OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems wi... There are potential issues related to the operational state of the scanner, specifically for tran... Class II NeuroLogica Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire ca... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jul 6, 2020 Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flex... BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential c... Class II Boston Scientific Corporation
Jun 30, 2020 IntelliVue MX700 patient monitor, model no. 865241 Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The de... Class II Philips North America, LLC
Jun 30, 2020 IntelliVue MX800 patient monitor, model no. 865240 Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The de... Class II Philips North America, LLC
Jun 26, 2020 Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-us... This voluntary recall is being conducted following three customer reports of the device cannula d... Class II Covidien Llc
Jun 26, 2020 Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-u... This voluntary recall is being conducted following three customer reports of the device cannula d... Class II Covidien Llc

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.