Browse Device Recalls

443 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 443 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 443 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jan 7, 2016	Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, ...	MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension De...	Class II	Maquet Cardiovascular Us Sales, Llc
Dec 16, 2015	Cardiosave Hybrid and rescue IABP	Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet...	Class II	Maquet Datascope Corp - Cardiac Assist Division
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 3, 2015	MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusaha...	Cracking may occur at the 15mm and 22mm ISO female connector.	Class II	Teleflex Medical
Nov 13, 2015	Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W ...	Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% vol...	Class II	Maquet Cardiovascular Us Sales, Llc
Aug 17, 2015	Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacture...	Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Pa...	Class II	Maquet Cardiovascular Us Sales, Llc
Aug 17, 2015	Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Ma...	Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Pa...	Class II	Maquet Cardiovascular Us Sales, Llc
Jun 10, 2015	Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Ar...	There is a potential issue that could result to collision between the C-arm of the angiography sy...	Class II	Maquet Cardiovascular Us Sales, Llc
May 29, 2015	The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light syst...	Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the j...	Class II	Maquet Cardiovascular Us Sales, Llc
Apr 2, 2015	FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use ...	In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas l...	Class I	Maquet Cardiovascular Us Sales, Llc
Mar 5, 2015	HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Produc...	A potential issue was detected that could result in blood leakage from the gas outlet port in all...	Class II	Maquet Cardiovascular Us Sales, Llc
Mar 5, 2015	Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox...	A potential issue was detected that could result in blood leakage from the gas outlet port in all...	Class II	Maquet Cardiovascular Us Sales, Llc
Mar 2, 2015	The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part numb...	Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the...	Class II	Maquet Cardiovascular Us Sales, Llc
Jan 30, 2015	Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)	Power supply malfunction complaints related to suboptimal thermal management.	Class II	Maquet Datascope Corp - Cardiac Assist Division
Jan 12, 2015	MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01...	Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm I...	Class I	Teleflex Medical
Jan 12, 2015	Servo-I ventilator system CO2 analyzer. Part number 65 23 588.	A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 anal...	Class II	Maquet Cardiovascular Us Sales, Llc
Dec 16, 2014	CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and...	Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration u...	Class II	Maquet Datascope Corp - Cardiac Assist Division
Dec 4, 2014	MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-81...	Connector mount cracks which may lead to a leak failure during use and necessitate immediate repl...	Class I	Teleflex, Inc.
Nov 5, 2014	Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coatin...	Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for ...	Class II	Maquet Cardiovascular Us Sales, Llc
Oct 17, 2014	Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxid...	Cardiohelp- i System may have a software issue that can potentially result in an erroneous displa...	Class II	Maquet Cardiovascular Us Sales, Llc
Aug 21, 2014	TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR In...	The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen ...	Class II	Maquet Medical Systems USA
Aug 13, 2014	Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump Sys...	An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the ...	Class II	Maquet Cardiovascular, LLC
Aug 11, 2014	LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group	During label reconciliation a duplicate serial number label was detected to be printed for the LI...	Class III	Datascope Corporation
Apr 16, 2014	Maquet PowerLED 700. Product Usage; To provide illumination to the surgi...	Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or sev...	Class II	Maquet Medical Systems USA
Mar 21, 2014	Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump....	Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Jan 31, 2014	MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat E...	The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardio...	Class II	Maquet Cardiovascular Us Sales, Llc
Dec 5, 2013	Compressor Mini To provide a supply of dry, filtered compressed air for a ...	Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.	Class II	Maquet Cardiovascular Us Sales, Llc
Oct 30, 2013	Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LL...	Maquet has received an increase in the number of complaints for "self-activated/remains activated...	Class II	Maquet Cardiovascular, LLC
Sep 20, 2013	Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use d...	MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D)....	Class II	Maquet Cardiovascular, LLC
Sep 12, 2013	MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manuf...	It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device ma...	Class II	Maquet Medical Systems USA
Aug 19, 2013	TEGRIS system Four labels of the Tegris System include: Emergency butt...	MAQUET has identified a potential issue that might occur because of the lack of an emergency stop...	Class II	Maquet Cardiovascular Us Sales, Llc
Aug 15, 2013	QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000...	The manufacturer has conducted a review of the results of product testing performed during the la...	Class II	Maquet Cardiovascular Us Sales, Llc
May 14, 2013	MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and ster...	The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain...	Class II	Maquet Cardiovascular Us Sales, Llc
Apr 26, 2013	MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The...	MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) ...	Class II	Maquet Cardiovascular Us Sales, Llc
Mar 7, 2013	MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0...	It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown...	Class II	Maquet Cardiovascular, LLC
Mar 7, 2013	Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator s...	When using the SERVO-i on battery power, in a very small number of cases, some battery modules di...	Class I	Maquet Cardiovascular Us Sales, Llc
Dec 26, 2012	Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO)...	ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 2, 2012	Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 B...	There is a potential issue with the screw tension of the extension device 1433.62A1 used with the...	Class II	Maquet Inc.
Jun 12, 2012	QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000...	It has come to firm's attention that, in some rare cases, the blood outlet connector on some mode...	Class II	Maquet Cardiovascular Us Sales, Llc
May 29, 2012	Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG K...	Certain pediatric arterial cannulas may have limited flexibility due to an increased length of th...	Class II	Maquet Inc.
Apr 13, 2012	Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Ver...	As a result of a small number of customer complaints, MAQUET conducted an investigation and ident...	Class II	Maquet Medical Systems, Usa
Mar 27, 2012	CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to i...	In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly...	Class II	Maquet Cardiovascular, LLC
Feb 20, 2012	FLOW-I Anesthesia System The system is intended for use in administrating ...	A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ...	Class I	Maquet Cardiovascular Us Sales, 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.