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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Date	Product	Reason	Class	Firm
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
Jul 5, 2018	CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050	the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during ...	Class II	CTL Medical Corporation
Jun 29, 2018	Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi...	An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could...	Class II	Luminex Corporation
Jun 26, 2018	Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP...	A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide ...	Class II	Encore Medical, Lp
May 23, 2018	Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation st...	Through an investigation, it has been determined that vials of Collagen packaged within the Colla...	Class III	Helena Laboratories, Corp.
May 23, 2018	Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studi...	Through an investigation, it has been determined that vials of Collagen packaged within the Colla...	Class III	Helena Laboratories, Corp.
May 23, 2018	Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing...	This email is to provide notification that, due to a software bug that has been corrected, the Ra...	Class II	Ortho Kinematics, Inc
May 16, 2018	The,K -ASSAY HP assay is intended for the quantitative determination of hum...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	C3 is an in vitro diagnostic assay for the quantitative determination of C3 i...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Transferrin is an in vitro diagnostic assay for the quantitative determinatio...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Apolipoprotein B is an in vitro diagnostic assay for the quantitative determi...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Immunoglobulin G is an in vitro diagnostic assay for the quantitative determi...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Immunoglobulin A is an in vitro diagnostic assay for the quantitative determi...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determ...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	Immunoglobulin M is an in vitro diagnostic assay for the quantitative determi...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 16, 2018	C4 is an in vitro diagnostic assay for the quantitative determination of C4 i...	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections ...	Class II	Abbott Laboratories, Inc
May 14, 2018	Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis co...	After receipt of a product complaint for the labeling, it was determined that this device does no...	Class II	Encore Medical, Lp
May 8, 2018	Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific...	Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nu...	Class II	Luminex Corporation
May 3, 2018	ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROC...	Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr...	Class II	Joerns Healthcare
May 3, 2018	P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP36...	Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr...	Class II	Joerns Healthcare
May 2, 2018	1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilat...	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr...	Class II	Galt Medical Corporation
May 2, 2018	TVS LPA, Catalog #: DIL-059-00	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr...	Class II	Galt Medical Corporation
May 2, 2018	1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog...	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr...	Class II	Galt Medical Corporation
May 2, 2018	1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) ...	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr...	Class II	Galt Medical Corporation
May 2, 2018	Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; ...	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr...	Class II	Galt Medical Corporation
May 2, 2018	Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-...	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr...	Class II	Galt Medical Corporation
May 2, 2018	Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr...	Class II	Galt Medical Corporation
May 2, 2018	1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05...	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr...	Class II	Galt Medical Corporation
Apr 6, 2018	Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Pa...	Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View ...	Class II	Orthofix, 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.