Browse Device Recalls

788 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 788 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 788 FDA device recalls in TX.

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DateProductReasonClassFirm
Dec 22, 2022 EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE... Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If t... Class II Encore Medical, LP
Nov 24, 2022 Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHI... Reaction vessels may contain a potential contaminant that could affect their optical performance. Class III Abbott Laboratories
Oct 31, 2022 Alcon Custom Pak Surgical Procedure Pack Due to difficulty removing the liner on the adhesive components of the affected drapes and as a r... Class II Alcon Research, LLC
Sep 14, 2022 ARIES SARS-CoV-2 Assay, REF: 50-10047 A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction ... Class II Luminex Corporation
Sep 1, 2022 Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge... Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the f... Class II Texas Medical Technology Inc.
Aug 12, 2022 EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... Class II Encore Medical, LP
Aug 12, 2022 EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Or... Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner impl... Class II Encore Medical, LP
Aug 10, 2022 Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F),... Bleed monitoring system device design error, causing the device to not power on and complete the ... Class II Saranas, Inc.
Jul 21, 2022 Medline CHEST TUBE REORDER NO: DYNJ36762A Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Co... Class II Medline Industries Inc.
Jul 14, 2022 ARIES SARS-CoV-2 Assay SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A pos... Class II Luminex Corporation
Jun 9, 2022 Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 P... Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves. Class II Alcon Research, LLC
Jun 9, 2022 REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
Jun 9, 2022 REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
Jun 9, 2022 REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be genera... Class II Abbott Laboratories
May 5, 2022 DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial ... Class II Encore Medical, LP
Apr 6, 2022 V8 Immunodisplacement Kit REF 1803 Due to microbial growth causing interference with interpretation. Class II Helena Laboratories, Corp.
Apr 5, 2022 Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Veri... Heater within the Verigene System may be outside of established temperature limits for assays wh... Class II Luminex Corporation
Apr 4, 2022 Diagnostic Kit SARS-cCo V Antigen Rapid Test COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the t... Class II USA Medical, LLC
Mar 16, 2022 Separation Technology Creamatocrit Plus, Catalog Number: 100-146 The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics ... Class II Stanbio Laboratory, LP
Feb 24, 2022 Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Steri... Surgical knives may contain incorrect description printed on handles. Specifically, some surgical... Class II International Science & Technology, LP, DBA Dia...
Feb 7, 2022 Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS... Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to compl... Class II Brius Technologies Inc.
Feb 7, 2022 Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX On... Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to compl... Class II Brius Technologies Inc.
Feb 7, 2022 Brius Patient Specific Brackets (components in a set of custom metal orthodon... Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to compl... Class II Brius Technologies Inc.
Feb 3, 2022 Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)003807... Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash b... Class II Abbott Laboratories, Inc
Jan 24, 2022 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the sa... Class II Argon Medical Devices, Inc
Dec 2, 2021 Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Mode... A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation lea... Class II LivaNova USA, Inc.
Nov 17, 2021 ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking... Class II Luminex Corporation
Nov 5, 2021 DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The... Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patie... Class II Dignitana, Inc.
Nov 1, 2021 Hanger-Bar 2P 45cm The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of ... Class II Human Care USA, Inc.
Nov 1, 2021 Hanger-Bar 2P 45cm The Hanger-Bar is being recalled due to the potential for the set screw loosening as a result of ... Class II Human Care USA, Inc.
Oct 28, 2021 OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 RE... Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a ... Class II Osteomed, LLC
Oct 4, 2021 SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE... Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. Class II Argon Medical Devices, Inc
Sep 30, 2021 MENTOR Saline-Filled Breast Implants are constructed from room temperature v... Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch port... Class II Mentor Texas, LP.
Sep 29, 2021 ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF ... Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... Class II Abbott Laboratories
Sep 29, 2021 ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/... Twelve software-related issues affecting software version 9.41 and earlier were identified. The i... Class II Abbott Laboratories
Sep 13, 2021 ARCH Leg Positioning System Due to the holes not being bored to the specific diameter, the locking pins are unable to engage ... Class II Innovative Orthopedic Technologies, LLC
Jul 26, 2021 Alinity ci-series System Control Module clinical chemistry and immunoassay an... Due to potential performance issues with software version 3.2.3 and earlier. Performance issues ... Class II Abbott Laboratories
Jul 12, 2021 Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vi... 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 Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent. 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 Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent. 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 Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent. 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 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

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.