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
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
Jun 19, 2020	EMPOWR Partial Knee Peg Drill; Model: 800-06-008.	There have been issues experienced with the peg preparation steps, specifically drilling of the F...	Class II	Encore Medical, LP
Jun 19, 2020	EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.	There have been issues experienced with the peg preparation steps, specifically drilling of the F...	Class II	Encore Medical, LP
Jun 19, 2020	ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. ...	Sterile introducer sheath set manufactured under one lot with different expiration dates.	Class II	Argon Medical Devices, Inc
Jun 15, 2020	Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Cultu...	An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negat...	Class II	Luminex Corporation
Jun 15, 2020	Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Cultur...	An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negat...	Class II	Luminex Corporation
Jun 8, 2020	ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERIC...	The device may power off without notification to the user resulting in a stoppage of negative pre...	Class II	KCI USA, INC.
Jun 8, 2020	1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External P...	1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The incr...	Class II	New Standard Device Inc
May 15, 2020	3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be...	Lack of pouch seal. Product is labelled as sterile.	Class II	TeDan Surgical Innovations LLC
May 15, 2020	PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usa...	Lack of pouch seal. Product is labelled as sterile.	Class II	TeDan Surgical Innovations LLC

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.