Browse Device Recalls

780 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 780 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 780 FDA device recalls.

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Date	Product	Reason	Class	Firm
Aug 10, 2016	Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syri...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Tran...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: T...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	Pediatric Kit with 30mL Flush Device, Item No. 46099-10 Product Usage: ...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	Monitoring Kit with 03mL Flush Device, Item No. 46080-57 Product Usage: ...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, D...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 4...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Rese...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 10, 2016	Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: ...	ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sam...	Class II	ICU Medical, Inc.
Aug 4, 2016	UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 7...	Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System t...	Class II	Beckman Coulter Inc.
Jul 11, 2016	Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product U...	Alere San Diego is initiating a voluntary recall for the Alere INRatio¿/INRatio¿2 PT/INR Monitori...	Class I	Alere San Diego, Inc.
Jun 24, 2016	Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage:...	There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery...	Class I	The Anspach Effort, Inc.
Jun 20, 2016	Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when ...	Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera h...	Class II	Karl Storz Endoscopy
Jun 20, 2016	PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control ...	Medtronic Navigation is recalling certain components of the PoleStar system (N20 / N30) because o...	Class II	Medtronic Navigation
Jun 16, 2016	AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro...	MultiQuant MD software where under certain conditions a user can be presented with incorrect qua...	Class II	Ab Sciex
Jun 16, 2016	AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro Diagn...	MultiQuant MD software where under certain conditions a user can be presented with incorrect qua...	Class II	Ab Sciex
Jun 16, 2016	AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagn...	MultiQuant MD software where under certain conditions a user can be presented with incorrect qua...	Class II	Ab Sciex
Jun 16, 2016	AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Nu...	MultiQuant MD software where under certain conditions a user can be presented with incorrect qua...	Class II	Ab Sciex
Apr 6, 2016	Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model ...	If used, the optional Swap feature copies programming parameters from the external pulse generato...	Class II	Nuvectra
Mar 17, 2016	enGen (TM) Laboratory Automation System configured with Thermo Scientific Rec...	The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may l...	Class II	Ortho-Clinical Diagnostics
Feb 24, 2016	Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instrume...	Wrong quantitative results may be displayed in a report from the device, which may potentially le...	Class II	Ab Sciex
Feb 16, 2016	CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: Th...	Siemens found a defective part in their production line which could increase risk of an electrica...	Class II	Siemens Medical Solutions USA, Inc
Jan 14, 2016	9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 ...	Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too h...	Class II	Cardiac Science Corporation
Dec 10, 2015	Flow-i Anesthesia System Product Usage: The indication for the Flow-i Ane...	Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit ...	Class I	Maquet Cardiovascular Us Sales, Llc
Dec 2, 2015	PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01...	The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical...	Class II	Gsi Group Inc
Nov 19, 2015	MOVES System Lithium Polymer Batteries The MOVES System is a portable comp...	Batteries found unresponsive after storage, not recognized by main device, and are perpetually en...	Class I	Thornhill Research Inc
Nov 19, 2015	MOVES System, an emergency ventilator with suction, oxygen concentrator and m...	Batteries found unresponsive after storage, not recognized by main device, and are perpetually en...	Class I	Thornhill Research Inc
Nov 10, 2015	Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: T...	Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el...	Class II	Siemens Healthcare Diagnostics Inc.
Nov 10, 2015	Reagent Management System (RMS) Dimension EXL with LM Product Usage: Th...	Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el...	Class II	Siemens Healthcare Diagnostics Inc.
Nov 10, 2015	Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: ...	Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el...	Class II	Siemens Healthcare Diagnostics Inc.
Nov 10, 2015	Reagent Management System (RMS) Dimension EXL with LM STM Product Usage:...	Siemens has identified RMS refrigeration compressors that are missing the safety cover on the el...	Class II	Siemens Healthcare Diagnostics Inc.
Sep 29, 2015	Medtronic Achieve Cables, model 990066. The sterile, single use only Electri...	64 units of Achieve Electrical Cables were shipped with a potential sterility breach.	Class II	Medtronic Inc.
Sep 10, 2015	Carto 3 EP Navigation System. Electro physiology system which views of the el...	Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed...	Class II	Biosense Webster, Inc.
Jul 8, 2015	Medline Electrical Clipper with Charging base The Electrical Surgical Cli...	Charging base of surgical clippers overheats and smokes.	Class II	Medline Industries Inc
Jun 12, 2015	ASP-1020 LipoTower with Aspiration Pump. Medical use.	There is potential risk of electrical shock if lead wires inside the device become detached and t...	Class II	MicroAire Surgical Instruments, LLC
Jun 12, 2015	ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.	There is potential risk of electrical shock if lead wires inside the device become detached and t...	Class II	MicroAire Surgical Instruments, LLC
Apr 29, 2015	HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Produ...	Failures of the splice repair kit if exposed to excessive force.	Class I	HeartWare Inc
Apr 2, 2015	Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Di...	Certain Dimension Integrated Chemistry Systems Instrument Power Configurations may have been inst...	Class II	Siemens Healthcare Diagnostics, Inc.
Mar 19, 2015	Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography syst...	potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connectio...	Class II	Siemens Medical Solutions USA, Inc
Mar 17, 2015	Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product...	Possible performance issue when used with specific AA-sized (LR6) batteries. The negative termina...	Class II	Medtronic Inc. Cardiac Rhythm Disease Management
Feb 24, 2015	Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electro...	The electrodes may fail to transmit signals.	Class II	Leonhard Lang Medizintechnik GmbH
Feb 19, 2015	Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove ...	Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electri...	Class II	Steris Corporation
Jan 9, 2015	The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable de...	Current labeling indicates that cycling improves device longevity in every programming scenario. ...	Class II	Medtronic Neuromodulation
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 19, 2014	ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside ...	When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor...	Class II	Philips Electronics North America Corporation
Oct 29, 2014	Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V...	If the power supply fan mounting screws are installed incorrectly, the ends of the screws may tou...	Class II	Respironics California Inc
Oct 22, 2014	Philips Expression MR200 MRI Patient Monitoring System.	The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; po...	Class II	Invivo Corporation
Oct 9, 2014	Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System	If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light h...	Class II	Cynosure, 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.