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