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Vehicle Safety

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

Infrastructure

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.

Clear
DateProductReasonClassFirm
Jul 4, 2014 AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro ... Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, f... Class II Advandx Inc
Jul 3, 2014 Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessori... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessor... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 8... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ C... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Access... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Cert... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 3, 2014 Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82... To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the... Class II Codman & Shurtleff, Inc.
Jul 1, 2014 Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument ... Risk of incorrect results from samples prepared with Panthera-Puncher 9 Class II PerkinElmer Health Sciences, Inc.
Jun 27, 2014 PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Pro... Potential for demographic information and test result to be mismatch. Class II PerkinElmer Health Sciences, Inc.
Jun 23, 2014 Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000... Product was held at temperature above the labeled recommended storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test ... Complaints of failed calibration. Class II Siemens Healthcare Diagnostics, Inc
Jun 23, 2014 SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test ... Complaints of failed calibration. Class II Siemens Healthcare Diagnostics, Inc
Jun 23, 2014 BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 ... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 3... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 P... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 23, 2014 BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC ... Products were held at improper storage temperature Class II Fresenius Medical Care Holdings, Inc.
Jun 13, 2014 Ingenia 1.5T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 1.5T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 3.0T R5, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 13, 2014 Ingenia 3.0T, magnetic resonance imaging system. For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear ... Class II Philips Medical Systems, Inc.
Jun 9, 2014 Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal ... An oversight in the implementation of the design change record resulted in outdated components be... Class II Arthrosurface, Inc.
Jun 6, 2014 Philips Medical System Allura Xper X-Ray Angiographic In certain circumstances, a software error can lead to a situation where the five minute fluorosc... Class II Philips Medical Systems, Inc.
Jun 3, 2014 ACL TOP CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP 300 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP 700 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP 700 LAS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP 700, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP (Base), automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 3, 2014 ACL TOP 500 CTS, automated coagulation laboratory instrument. Potential for sample misidentification. Class II Instrumentation Laboratory Co.
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Co... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 722038... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, f... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 722... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
Jun 2, 2014 Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centa... Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles Class II Siemens Healthcare Diagnostics, Inc
Jun 2, 2014 SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fast... Sterility of device is compromised due to breach in sterile barrier Class II Smith & Nephew, Inc. Endoscopy Division
May 30, 2014 ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), ... The solid phase reagent in some of the ADVIA Centaur¿ TnI -Ultra ReadyPacks¿, lot 084, is darker ... Class II Siemens Healthcare Diagnostics, Inc
May 23, 2014 RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurem... RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters ... Class II Siemens Healthcare Diagnostics Inc
May 22, 2014 Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management ... RAPIDComm¿ 5.0 Screen Layout will display incorrect test names Class III Siemens Healthcare Diagnostics Inc
May 22, 2014 IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue I... IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume... Class II Philips Medical Systems, Inc.
May 15, 2014 Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T pro... Ingenia customers have experienced clamping of the foot under the central column of the Height Ad... Class II Philips Medical Systems, Inc.
May 15, 2014 Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T prod... Ingenia customers have experienced clamping of the foot under the central column of the Height Ad... Class II Philips Medical Systems, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, Inc.
May 14, 2014 NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF:... SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification Class II NxStage Medical, 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.