Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Date	Product	Reason	Class	Firm
Nov 25, 2014	DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog ...	While servicing a unit at a customer site, a field engineer discovered a broken bolt from the car...	Class II	Carestream Health Inc
Nov 25, 2014	TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequen...	A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath cath...	Class II	St Jude Medical
Nov 25, 2014	SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 4...	Nonin Medical is conducting a recall of certain regional oximetry sensors and associated product...	Class II	Nonin Medical, Inc
Nov 24, 2014	Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 ...	The syringe carrier is missing components: a damper and spring.	Class II	Owen Mumford USA, Inc.
Nov 24, 2014	Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number...	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in...	Class II	Arthrosurface, Inc.
Nov 24, 2014	Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage:...	Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 24, 2014	Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: ...	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in...	Class II	Arthrosurface, Inc.
Nov 24, 2014	Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8...	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in...	Class II	Arthrosurface, Inc.
Nov 24, 2014	Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Num...	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in...	Class II	Arthrosurface, Inc.
Nov 24, 2014	Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number...	Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in...	Class II	Arthrosurface, Inc.
Nov 21, 2014	Tracheopart Set (Left), Sterile	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 21, 2014	Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock...	Needle is not captured in the needle safety sheath in specific lots.	Class II	Smiths Medical ASD, Inc.
Nov 21, 2014	HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company....	Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prio...	Class II	Instrumentation Laboratory Co.
Nov 21, 2014	DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 3...	This recall has been initiated due to potential false positives results when using the test to sc...	Class II	Express Diagnostics Int'l., Inc.
Nov 21, 2014	BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes...	The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the ...	Class II	Becton Dickinson & Co.
Nov 21, 2014	White Bronchial Double Lumen Tube Set (Right) Sterile	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 21, 2014	Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 21, 2014	Tracheopart Set (Right), Sterile	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 21, 2014	Bone Screw, self-tapping The Trilogy shells are available in three configura...	Analysis of returned complaint devices, product in inventory, and device manufacturing records ha...	Class II	Zimmer Manufacturing B.V.
Nov 21, 2014	Bronchial One Lumen Tube - Right	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 21, 2014	Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 ...	Needle is not captured in the needle safety sheath in specific lots.	Class II	Smiths Medical ASD, Inc.
Nov 21, 2014	Bronchial Double Lumen Tube Set (Left), Sterile	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 21, 2014	Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock...	Needle is not captured in the needle safety sheath in specific lots.	Class II	Smiths Medical ASD, Inc.
Nov 21, 2014	Bronchial One Lumen Tube - Left	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 21, 2014	BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For pati...	The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the ...	Class II	Becton Dickinson & Co.
Nov 21, 2014	Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ...	Affected product may have compromised sterility due to packaging defects. It was determined that ...	Class II	Atricure Inc
Nov 21, 2014	TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (H...	Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System ...	Class II	TomoTherapy Incorporated
Nov 21, 2014	Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescen...	The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging...	Class II	Intuitive Surgical, Inc.
Nov 21, 2014	Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescen...	The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging...	Class II	Intuitive Surgical, Inc.
Nov 21, 2014	Bronchial Double Lumen Tube Set (Right), Sterile	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 21, 2014	Carlens Bronchial Double Lumen Tube Set (Left) Sterile	Customer complaints reporting that the cobb connector detached from the main connector prior to use.	Class II	Teleflex, Inc.
Nov 20, 2014	ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the ...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infus...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
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 20, 2014	Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-0...	During an investigation of instrument logs it was determined that In specific circumstances invol...	Class II	Phadia US Inc
Nov 20, 2014	ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusi...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are in...	Failure to submit a 510(k) for device labeling changes.	Class II	Unistrip Technologies LLC
Nov 20, 2014	ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the ...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64...	Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a ...	Class II	Boston Scientific Corp
Nov 20, 2014	ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infus...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the ...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for t...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusi...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upg...	VCG battery ignited in a VCG unit when recharging.	Class II	Philips Medical Systems, Inc.
Nov 20, 2014	ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the ...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusi...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 20, 2014	ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the...	Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-C...	Class II	Roche Diagnostics Operations, Inc.
Nov 19, 2014	Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delive...	Lotus valve became unlocked during release from the delivery system. This may lead to percutaneo...	Class I	Boston Scientific Corporation
Nov 19, 2014	iPlan RT Dose is a stereotactic radiation treatment planning system that is i...	iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when us...	Class II	Brainlab AG

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.