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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

816 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 816 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 816 FDA device recalls in TX.

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DateProductReasonClassFirm
Dec 10, 2018 VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device i... No results/incorrect results due to failure of the hybridization heater. Class II Luminex Corporation
Nov 16, 2018 Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The fir... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... Class II LivaNova USA Inc
Nov 16, 2018 Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The fi... This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the device... Class II LivaNova USA Inc
Nov 16, 2018 The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), cons... Lead impedance values reported by the affected VNS generator will be higher compared to those rep... Class II LivaNova USA Inc
Nov 16, 2018 VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly This recall is being initiated due to reports that that the therapy programming tablet with softw... Class II LivaNova USA Inc
Nov 16, 2018 Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-... The product was packaged with the Instructions for Use for a different product (Ascension First C... Class III Ascension Orthopedics, Inc
Nov 13, 2018 EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surg... There is a potential the joint in the suspension of the device is insufficiently assembled. Class II Stryker Communications
Oct 16, 2018 (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, R... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/b... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx.... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, N... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm n... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-steri... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Conver... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Sto... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 16, 2018 (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straig... The seal formed on the edge of the pouch may be incomplete, which could result in a loss of steri... Class II Argon Medical Devices, Inc
Oct 11, 2018 St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6... The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed w... Class II St. Jude Medical, Inc.
Sep 21, 2018 Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset... Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting ... Class II Encore Medical, Lp
Sep 19, 2018 Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX... Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failur... Class II Encore Medical, Lp
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

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.