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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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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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
May 7, 2021 LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 Magellan has received reports that control tests of either the Low-Control and/or the High-Contro... Class I Magellan Diagnostics, Inc.
May 4, 2021 Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 11000... The component part numbers intended for shipment to a third-party, where they are further process... Class I Medtronic Vascular
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFligh... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GX... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
Apr 30, 2021 Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The S... Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned... Class II Fujifilm Medical Systems U.S.A., Inc.
Apr 28, 2021 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory ... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powd... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic ... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each int... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage s... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 g... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 28, 2021 Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are ... Exposed to freezing temperatures due to refrigerated truck malfunctions Class II Fresenius Medical Care Holdings, Inc.
Apr 23, 2021 Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... Class II Philips North America Llc
Apr 23, 2021 Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated ... The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... Class II Philips North America Llc
Apr 21, 2021 Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagno... Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This ca... Class II Siemens Healthcare Diagnostics, Inc
Apr 15, 2021 Colpassist Vaginal Positioning Device - Product Usage: intended for use in ge... Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render t... Class II Boston Scientific Corporation
Apr 15, 2021 UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usa... Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render th... Class II Boston Scientific Corporation
Apr 13, 2021 BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to pro... Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury Class II Philips North America Llc
Apr 8, 2021 CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for int... Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw Class II Smith & Nephew, Inc.
Apr 6, 2021 LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Pr... The firm received a complaint regarding particulate found in the packaging foam that could contam... Class II LeMaitre Vascular, Inc.
Mar 29, 2021 Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor)... Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of... Class II Philips North America Llc
Mar 26, 2021 The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system cont... An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal... Class II Boston Scientific Corporation
Mar 23, 2021 Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for moni... Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of h... Class II Philips North America, LLC
Mar 23, 2021 Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... Potential for the pouch to contain an extra laminate layer, creating the potential for the device... Class II Covidien Llc
Mar 18, 2021 AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intende... AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideli... Class II Fresenius Medical Care Holdings, Inc.
Mar 16, 2021 EXALT Controller - Product Usage: intended for use with a Boston Scientific e... May have been programmed with a less than optimal brightness setting resulting in a darker than ... Class III Boston Scientific Corporation
Mar 2, 2021 Synapse PACS - Radiological Image Processing System - Product Usage: intended... The wrong patient information may be displayed in the viewer or PowerJacket. Class II Fujifilm Medical Systems U.S.A., Inc.
Mar 1, 2021 Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0... Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software U... Class II Abiomed, Inc.
Feb 26, 2021 BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended t... The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... Class II Covidien Llc
Feb 26, 2021 CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to... The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... Class II Covidien Llc
Feb 24, 2021 Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Periphe... Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shor... Class II Access Vascular, Inc.
Feb 22, 2021 Incisive CT Computed Tomography X-ray System Model: 728143 Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2... Class II Philips North America Llc
Feb 18, 2021 ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DC... Class II Fujifilm Medical Systems U.S.A., 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.