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
Nov 20, 2014	Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Ther...	The recalled product was distributed with an incorrect serial number printed on the device's label.	Class II	Cyberonics, Inc
Nov 19, 2014	CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only M...	KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component o...	Class II	KCI USA, INC.
Nov 11, 2014	Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile ...	The product is sold and labeled as EO sterilized, however the units were not sterilized prior to ...	Class II	Alcon Research, Ltd.
Oct 30, 2014	INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. S...	Alcon is conducting a medical device recall due to the possible presence of pieces of tubing in t...	Class II	Alcon Research, Ltd.
Oct 27, 2014	Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switc...	Potential breach of sterile barrier due to defective product tray.	Class II	ArthroCare Medical Corporation
Oct 6, 2014	Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters ...	Patients have experienced a bad taste associated with the filters.	Class II	Alliance Tech Medical, Inc
Oct 6, 2014	INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718...	The recalling firm received complaints related to leakage from the tubing near the white luer of ...	Class II	Alcon Research, Ltd.
Sep 29, 2014	ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic ...	Product is mislabeled.	Class II	4-Web Inc.
Sep 24, 2014	Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed...	The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay eng...	Class II	Joerns Healthcare
Sep 18, 2014	Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 ...	The single leg of the PAY connector has been observed to become detached.	Class II	Dokitz NovoSci
Sep 18, 2014	V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration an...	A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufa...	Class II	KCI USA, Inc.
Sep 12, 2014	Prescription eyeglass safety lenses. Vision correction	Prescription eyeglass safety lenses did not meet specifications.	Class II	Eyemart Express Ltd
Aug 15, 2014	LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Ac...	Product was distributed past its expiration date.	Class II	Apollo Endosurgery Inc
Jul 29, 2014	Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as p...	The Directions for Use (DFU) manual contains information for devices that are not approved in the...	Class II	St. Jude Medical, Inc.
Jul 29, 2014	Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as p...	The Directions for Use (DFU) manual contains information for devices that are not approved in the...	Class II	St. Jude Medical, Inc.
Jul 25, 2014	Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (...	Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its ca...	Class II	Estill Medical Technologies, Inc
Jul 25, 2014	GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-S...	The adhesive used in the product could dislodge when objects are inserted through the valve which...	Class II	Galt Medical Corporation
Jul 25, 2014	GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO ...	The adhesive used in the product could dislodge when objects are inserted through the valve which...	Class II	Galt Medical Corporation
Jul 2, 2014	EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Us...	The device labeling is stamped with 330cc and the device is actually 380cc device.	Class II	Mentor Texas, LP.
Jun 5, 2014	UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 320...	UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at...	Class II	Argon Medical Devices, Inc
Jun 5, 2014	UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 3...	UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at...	Class II	Argon Medical Devices, Inc
Jun 5, 2014	UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524...	UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during at...	Class II	Argon Medical Devices, Inc
Jun 3, 2014	eye-pak 7407 Tray Support Cover REF 8065740745	The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot...	Class II	Alcon Research, Ltd.
May 19, 2014	CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50	Blade can shift during shipping which makes the product ineffective.	Class II	KCI USA, Inc.
May 16, 2014	Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Numbe...	Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actua...	Class II	Alcon Research, Ltd.
Apr 7, 2014	Lipase Reagent, 7D80. Used to measure lipase in human serum on the Archite...	Package inserts have incorrect SmartWash parameters for Triglyceride.	Class II	Abbott Laboratories, Inc
Apr 2, 2014	Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of ...	The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Ge...	Class II	Genesys Orthopedics Systems, LLC
Mar 31, 2014	EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455	The voluntary recall is due to the needle set not meeting its specifications.	Class II	Vidacare Corporation
Mar 17, 2014	SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the servi...	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S...	Class II	Stryker Communications
Mar 17, 2014	BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the s...	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S...	Class II	Stryker Communications
Mar 17, 2014	BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the ...	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S...	Class II	Stryker Communications
Mar 17, 2014	SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the ser...	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S...	Class II	Stryker Communications
Mar 17, 2014	SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attach...	During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the S...	Class II	Stryker Communications
Mar 8, 2014	Neusoft NeuViz 64 Multi-slice CT Scanner System	The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing...	Class II	Neusoft Medical System Co
Feb 7, 2014	FMP X-alt Acetabular Liner This acetabular liner is intended for use with ...	Packaging error -- two different types and sizes of acetabular liners used during hip replacement...	Class II	Djo Surgical
Jan 30, 2014	PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena ...	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is...	Class II	KCI USA, INC.
Jan 30, 2014	PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) P...	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is...	Class II	KCI USA, INC.
Jan 30, 2014	PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena In...	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is...	Class II	KCI USA, INC.
Jan 30, 2014	PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena ...	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is...	Class II	KCI USA, INC.
Jan 30, 2014	PRE2001: Prevena Incision Management Customizable System Box Product Usage...	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is...	Class II	KCI USA, INC.
Jan 30, 2014	PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: ...	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is...	Class II	KCI USA, INC.
Jan 30, 2014	PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Man...	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is...	Class II	KCI USA, INC.
Jan 30, 2014	PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: Th...	Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is...	Class II	KCI USA, INC.
Dec 9, 2013	Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 20...	A sharp edge on the cannulated tip of the device may damage or cut a suture.	Class II	ArthroCare Medical Corporation
Nov 26, 2013	Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver...	Orthofix received 6 complaints which resulted in a reportable events due to extended surgical tim...	Class II	Orthofix, Inc.
Nov 20, 2013	All brochures printed before November 20, 2013 for the HyperBlue 1530 medical...	Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had...	Class II	Hyperion Medical
Oct 29, 2013	Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Tit...	There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fractu...	Class II	Orthofix, Inc
Oct 18, 2013	CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"	Product has the potential to have a clear debris on the tip of the needle.	Class II	Intra Pump Infusion Systems
Sep 13, 2013	Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparosc...	CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed...	Class II	CooperSurgical, Inc. D.B.A. Lone Star Medical P...
Sep 11, 2013	The Rotoprone therapy System is an advanced patient care system for the treat...	The lock pin can become stuck in the "in" position during the manual rotation, resulting in the i...	Class II	ArjoHuntleigh 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.