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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.