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.

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Date	Product	Reason	Class	Firm
Sep 22, 2014	Digital Mobile X-ray Systems used to take diagnostic radiographic exposures o...	There is a potential for unintended and erratic motion.	Class II	Virtual Imaging, Inc.
Sep 22, 2014	GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignm...	Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension R...	Class II	Medacta Usa
Sep 22, 2014	Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; ...	CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorb...	Class II	C P Medical, Inc.
Sep 20, 2014	Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. ...	TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be...	Class I	Trivascular, Inc
Sep 19, 2014	External power supply adaptors that accompany Clinitek Status Power Supply Ad...	The external power supply for the Clintek Status analyzer, which is provided separately, is damag...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 19, 2014	IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 1...	Customer complaints were received for positive bias reported on the controls used on the IMMULITE...	Class II	Siemens Healthcare Diagnostics
Sep 19, 2014	Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Lox...	Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)	Class II	Straumann USA, LLC
Sep 19, 2014	External power supply adaptors that accompany Clinitek Status Connect System ...	The external power supply for the Clintek Status analyzer, which is provided separately, is damag...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 19, 2014	External power supply adaptors that accompany Clinitek Status+ The Clinite...	The external power supply for the Clintek Status analyzer, which is provided separately, is damag...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 19, 2014	GE Healthcare Carescape Patient Data Module	GE Healthcare has recently become aware of a potential safety issue to the ECG calculations foll...	Class II	GE Healthcare, LLC
Sep 19, 2014	MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag...	Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer	Class II	Orthohelix Surgical Designs Inc
Sep 18, 2014	Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number:...	Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi...	Class I	Covidien LLC
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	Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A	Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi...	Class I	Covidien LLC
Sep 18, 2014	MediChoice¿ Multifunction Electrode Part Number: MC171 OH	Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi...	Class I	Covidien LLC
Sep 18, 2014	Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number:...	Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi...	Class I	Covidien LLC
Sep 18, 2014	EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: I...	Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discont...	Class II	Intuitive Surgical, Inc.
Sep 18, 2014	Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product ...	A potential issue with false high values.	Class II	Biomerica
Sep 18, 2014	Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation E...	Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi...	Class I	Covidien LLC
Sep 18, 2014	Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiratio...	The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a sa...	Class II	Siemens Medical Solutions USA, Inc
Sep 18, 2014	Multi-Lumen Central Venous Catheterization Kit	Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot numbe...	Class II	Arrow International Inc
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 18, 2014	Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pr...	Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Phi...	Class I	Covidien LLC
Sep 17, 2014	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%...	The affected lots could have NBF concentrations that are lower or higher than the desired specifi...	Class I	Richard-Allan Scientific Company
Sep 17, 2014	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10%...	The affected lots could have NBF concentrations that are lower or higher than the desired specifi...	Class I	Richard-Allan Scientific Company
Sep 17, 2014	ProClear Toric contact lenses are made from a material containing 62%...	Routine quality monitoring system has identified that a limited number of lots were manufactured...	Class III	Cooper Vision Caribbean Corp.
Sep 17, 2014	Compress Face Reamer Product Usage: Correction of revision of unsuccess...	Investigation determined that units supplied were missing the 4x21 degree helix angle.	Class II	Biomet, Inc.
Sep 17, 2014	Richard-Allan Scientific Specimen Transportation System. 10% NBF is used t...	The affected lots could have NBF concentrations that are lower or higher than the desired specifi...	Class I	Richard-Allan Scientific Company
Sep 17, 2014	Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% ...	The affected lots could have NBF concentrations that are lower or higher than the desired specifi...	Class I	Richard-Allan Scientific Company
Sep 17, 2014	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11...	Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ...	Class II	Boston Scientific CRM Corp
Sep 17, 2014	Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue...	The affected lots could have NBF concentrations that are lower or higher than the desired specifi...	Class I	Richard-Allan Scientific Company
Sep 17, 2014	Richard-Allan Scientific Specimen Transportation System. Product Usage: 10...	The affected lots could have NBF concentrations that are lower or higher than the desired specifi...	Class I	Richard-Allan Scientific Company
Sep 17, 2014	Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is ...	The affected lots could have NBF concentrations that are lower or higher than the desired specifi...	Class I	Richard-Allan Scientific Company
Sep 17, 2014	nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic...	An error was discovered in the interpretation of certain DICOM header tags that may lead to incor...	Class II	NordicNeuroLab AS
Sep 17, 2014	Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094...	The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not b...	Class II	Siemens Medical Solutions USA, Inc
Sep 17, 2014	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat...	Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ...	Class II	Boston Scientific CRM Corp
Sep 17, 2014	EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical...	Intuitive Surgical is initiating a voluntary correction relating to the labeling and software ass...	Class II	Intuitive Surgical, Inc.
Sep 17, 2014	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Gene...	A failure of a specific component may prevent the ventilators from operating on AC power or trans...	Class I	Respironics California Inc
Sep 16, 2014	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8...	Product sterility is not assured	Class II	Bio-Detek, Inc.
Sep 16, 2014	Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ...	Particulate matter found inside the fluid path.	Class I	Baxter Healthcare Corp
Sep 16, 2014	Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen...	Particulate matter found inside the fluid path.	Class I	Baxter Healthcare Corp
Sep 16, 2014	ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012...	Product sterility is not assured	Class II	Bio-Detek, Inc.
Sep 16, 2014	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwi...	Product sterility is not assured	Class II	Bio-Detek, Inc.
Sep 16, 2014	ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwi...	Product sterility is not assured	Class II	Bio-Detek, Inc.
Sep 15, 2014	ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. C...	Increased imprecision and positive bias is observed with patient samples and negative controls an...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 15, 2014	Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage Sys...	tubing within the system that drains CSF may leak or disconnect from the joints and may result in...	Class II	Codman & Shurtleff, Inc.
Sep 15, 2014	Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagno...	Increased imprecision and positive bias is observed with patient samples and negative controls an...	Class II	Siemens Healthcare Diagnostics, Inc
Sep 15, 2014	AC Powered adjustable bed frame. AC powered adjustable bed frame used in n...	Firm received several complaints that the head deck actuator bracket had separated from the bed f...	Class II	Primus Medical LLC
Sep 15, 2014	GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgica...	mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation o...	Class II	GE OEC Medical Systems, Inc
Sep 15, 2014	Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Sy...	tubing within the system that drains CSF may leak or disconnect from the joints and may result in...	Class II	Codman & Shurtleff, 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.