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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

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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

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
Jul 12, 2021 Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic rea... Deterioration in the stability of the reagents which has resulted in lower than expected or out o... Class III Stanbio Laboratory, LP
Jul 12, 2021 Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vit... A design defect (hardware and software) allows liquid waste pressure to build up and potentially ... Class II Abbott Laboratories, Inc
Jul 8, 2021 Scorpion Portal Vein Access Set - Product Usage: used to gain access to the h... As a result of design changes, sheaths have exhibited cracking/breaking at the tips. Class II Argon Medical Devices, Inc
Jun 28, 2021 AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part ... Complaints have been received concerning the humeral stem failing to mate with the broach handles... Class II Encore Medical, LP
Jun 24, 2021 CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-1... There is the potential bacterial including Nontuberculous mycobacterial (NTM) to grow in the wate... Class II CardioQuip, LLC
Jun 10, 2021 REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
Jun 10, 2021 REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
Jun 10, 2021 REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Ki... There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples... Class II Abbott Laboratories
Jun 10, 2021 REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architec... There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) sample... Class II Abbott Laboratories
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, C... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE ... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
May 12, 2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. ... Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains ... Class II Encore Medical, LP
May 12, 2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz.... Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains ... Class II Encore Medical, LP
May 12, 2021 CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: ... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
May 12, 2021 CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)0086... Labeling does not include guidance for proper water-quality maintenance and device inspection fo... Class II CardioQuip, LLC
Apr 16, 2021 ARIES HSV 1&2 Assay, Part Number/REF 50-10017 Impacted lot may leak inside the ARIES instrument. Class II Luminex Corporation
Mar 11, 2021 Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Sw... Verification and validation of the virus transport medium tubes was not provided to FDA prior to ... Class II Krishe Inc
Mar 11, 2021 Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 p... Verification and validation of the virus transport medium tubes was not provided to FDA prior to ... Class II Krishe Inc
Mar 11, 2021 Dasky Disposable Sampling Tube, REF VSM03, Contents: Sterile 0.85% Saline - 5... Verification and validation of the virus transport medium tubes was not provided to FDA prior to ... Class II Krishe Inc
Mar 11, 2021 Dasky Disposable Sampling Tube, REF VSM02, Contents: Transport Media - 50, Na... Verification and validation of the virus transport medium tubes was not provided to FDA prior to ... Class II Krishe Inc
Mar 2, 2021 Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - Fa... Due to Products being incorrect labeling "for diagnostic use" and labelled with an unsupported 24... Class II AZURE BIOTECH INC
Feb 5, 2021 DJO EMPOWR KNEE Femoral Sizer Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show th... Class II Encore Medical, LP
Feb 2, 2021 Alcon Custom Ophthalmic Surgical Procedure Packs Reports have been received concerning mold found on gowns included in custom ophthalmic surgery ... Class II Alcon Research, LLC
Jan 29, 2021 S-Series Equipment Management System; Model Number(s):0682400550; UDI: 076133... The manufacturer has become aware that there is a likelihood that the S-Series Equipment Manageme... Class II Stryker Communications
Jan 28, 2021 Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve ba... It was identified that tissue culture bags were incorrectly labeled as free of phthalates. Class III OriGen Biomedical, Inc.
Jan 5, 2021 Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascad... Intermittent potential for shorter than expected clot times. Class II Helena Laboratories, Corp.
Dec 28, 2020 Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixatio... Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. Class II New Standard Device Inc
Dec 18, 2020 AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, ... Labeling update; To reduce the risk of false positive/false negative results the IFU for the adap... Class II Ansh Labs, LLC
Dec 14, 2020 PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Nee... There is a potential that a catheter convenience set contains a 21G access needle instead of the ... Class II Prytime Medical Devices, Inc.
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, ... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C,... Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separ... Class II Argon Medical Devices, Inc
Nov 23, 2020 APEX Compounding System Control Panel Module, REF: 601238, Product Code AX100... There is the potential for the compounding system to not immediately interrupt compounding and al... Class II B Braun Medical, Inc.
Nov 23, 2020 APEX Compounding System Control Panel Module, REF: 601224, Product Code AX100... There is the potential for the compounding system to not immediately interrupt compounding and al... Class II B Braun Medical, Inc.
Nov 23, 2020 APEX Compounding System Control Panel Module, REF: 601237, Product Code AX100... There is the potential for the compounding system to not immediately interrupt compounding and al... Class II B Braun Medical, Inc.
Nov 16, 2020 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Ce... Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in ... Class II Galt Medical Corporation
Nov 12, 2020 VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment... During internal testing, it was found that upon a device reset, the Generator exhibits the incorr... Class II LivaNova USA Inc
Nov 9, 2020 K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATE... Due to complaints received associated with cracked/split test tube caps. Class II Helena Laboratories, Corp.
Oct 29, 2020 PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Co... There is a potential that catheters may have incorrectly marked balloon and arterial lines. Th... Class II Prytime Medical Devices, Inc.
Sep 28, 2020 VNS Therapy¿ AspireSR¿ Generator Due to an extra digit being inadvertently added to the serial number of a subset of implantable p... Class II LivaNova USA Inc
Sep 9, 2020 EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Si... Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the s... Class II Encore Medical, LP
Aug 31, 2020 AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Nu... Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. Class II Encore Medical, LP
Aug 24, 2020 Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXI... The third-party brand latex micro surgical gloves packaged within specific custom packs may have ... Class II Alcon Research, LLC
Aug 17, 2020 Speed Stitch Needle Cassette Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result,... Class II ArthroCare Corporation
Aug 7, 2020 RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00... Product may be mislabeled with the size etched onto products differing from the size information ... Class II Encore Medical, LP
Aug 7, 2020 RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 Product may be mislabeled with the size etched onto products differing from the size information ... Class II Encore Medical, LP
Aug 3, 2020 DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contai... There is a potential for the retaining pin of the tibial punch handle to become loose and fall ou... Class II Encore Medical, LP

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.