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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

797 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 797 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 797 FDA device recalls in TX.

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DateProductReasonClassFirm
Sep 14, 2018 VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pac... Potential to lead to a false negative results. Class II Luminex Corporation
Sep 7, 2018 APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Clas... The firm identified customer sites where modules which the safety pacemaker label is missing. Inf... Class II Abbott Laboratories, Inc
Aug 28, 2018 Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The AR... There is a potential to generate falsely elevated serum or plasma chloride results when using the... Class II Abbott Laboratories, Inc
Aug 21, 2018 Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications:... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indicati... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo... The catheter failed the endotoxin testing. Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: ... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinfo... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: ... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 21, 2018 Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications:... These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual ca... Class II OriGen Biomedical, Inc.
Aug 8, 2018 ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic ... The positive control on some tests of the lots did not appropriately react within the specified t... Class II Helena Laboratories, Corp.
Aug 8, 2018 ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic U... The positive control on some tests of the lots did not appropriately react within the specified t... Class II Helena Laboratories, Corp.
Jul 25, 2018 Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Pro... There was a potential that a 25-gauge infusion cannula may be included within the procedure pak i... Class II Alcon Research LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning Sterilization Protocol for Trillia... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for Tri... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 19, 2018 Instructions for Use and Surgical Cleaning and Sterilization Protocol for: ... Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised... Class II Trilliant Surgical, LLC
Jul 18, 2018 Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21. The product has a stability issue which may lead to an error code indicating "Unable to calculate... Class II Abbott Laboratories, Inc
Jul 18, 2018 Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341. The product has a stability issue which may lead to an error code indicating "Unable to calculate... Class II Abbott Laboratories, Inc
Jul 17, 2018 Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The... There is a potential to generate incorrect results on the instrument if particular error codes ar... Class II Abbott Laboratories, Inc
Jul 17, 2018 Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: Th... There is a potential to generate incorrect results on the instrument if particular error codes ar... Class II Abbott Laboratories, Inc
Jul 17, 2018 Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The... There is a potential to generate incorrect results on the instrument if particular error codes ar... Class II Abbott Laboratories, Inc
Jul 17, 2018 Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnifi... Potential for the optical head to detach from the stand due to the lack of thread adhesive. Class II Alcon Research Laboratories Ltd.
Jul 10, 2018 djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S... The retaining ring on the neck trials has a potential to fail interoperatively. Class II Encore Medical, LP
Jul 5, 2018 CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during ... Class II CTL Medical Corporation
Jul 5, 2018 CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during ... Class II CTL Medical Corporation
Jun 29, 2018 Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi... An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could... Class II Luminex Corporation
Jun 26, 2018 Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP... A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide ... Class II Encore Medical, Lp
May 23, 2018 Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st... Through an investigation, it has been determined that vials of Collagen packaged within the Colla... Class III Helena Laboratories, Corp.
May 23, 2018 Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi... Through an investigation, it has been determined that vials of Collagen packaged within the Colla... Class III Helena Laboratories, Corp.
May 23, 2018 Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing... This email is to provide notification that, due to a software bug that has been corrected, the Ra... Class II Ortho Kinematics, Inc
May 16, 2018 The,K -ASSAY HP assay is intended for the quantitative determination of hum... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 C3 is an in vitro diagnostic assay for the quantitative determination of C3 i... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Transferrin is an in vitro diagnostic assay for the quantitative determinatio... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Apolipoprotein B is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Immunoglobulin G is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Immunoglobulin A is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determ... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 Immunoglobulin M is an in vitro diagnostic assay for the quantitative determi... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 16, 2018 C4 is an in vitro diagnostic assay for the quantitative determination of C4 i... An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ... Class II Abbott Laboratories, Inc
May 14, 2018 Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis co... After receipt of a product complaint for the labeling, it was determined that this device does no... Class II Encore Medical, Lp
May 8, 2018 Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific... Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nu... Class II Luminex Corporation
May 3, 2018 ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROC... Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr... Class II Joerns Healthcare
May 3, 2018 P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP36... Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr... Class II Joerns Healthcare

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.