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 8, 2019	Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Num...	The affected flat screen monitor holders might not be compliant with grounding requirements. As a...	Class II	GETINGE US SALES LLC
Jan 8, 2019	Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuratio...	The affected flat screen monitor holders might not be compliant with grounding requirements. As a...	Class II	GETINGE US SALES LLC
Jan 8, 2019	Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE, Configuration Par...	The affected flat screen monitor holders might not be compliant with grounding requirements. As a...	Class II	GETINGE US SALES LLC
Jan 8, 2019	Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD...	The affected flat screen monitor holders might not be compliant with grounding requirements. As a...	Class II	GETINGE US SALES LLC
Oct 25, 2018	QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000...	There is a potential for blood leakage at the blood inlet connector when using the reducing screw...	Class I	Maquet Cardiovascular Us Sales, Llc
Oct 25, 2018	QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10...	There is a potential for blood leakage at the blood inlet connector when using the reducing screw...	Class I	Maquet Cardiovascular Us Sales, Llc
Sep 20, 2018	Cardiosave Rescue IABP, Part Number 0998-UC-0800-83	There is a potential for interruption and/or inability to start therapy to the patient prior to o...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Sep 20, 2018	Cardiosave Hybrid IABP, Part Number 0998-00-0800-53	There is a potential for interruption and/or inability to start therapy to the patient prior to o...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Jun 14, 2018	VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD5688219...	Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head det...	Class II	Maquet SAS
May 14, 2018	Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with...	This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre...	Class II	Maquet Cardiopulmonary Ag
May 14, 2018	Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector...	This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre...	Class II	Maquet Cardiopulmonary Ag
May 14, 2018	Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with...	This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could bre...	Class II	Maquet Cardiopulmonary Ag
May 3, 2018	CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-...	Ingress of fluids into the device can affect various electronic circuit boards which would preven...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Apr 19, 2018	VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until J...	Potential keypad failure on VOLISTA StandOP Surgical Lights.	Class II	Maquet SAS
Apr 4, 2018	CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 ...	There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to ...	Class II	Maquet Cardiopulmonary Ag
Mar 30, 2018	MR Surgical Suite Option Product The MR Surgical Option when integrated wi...	There is a potential safety issue with the table transfer release of the MR Surgical Suite System...	Class II	GE Medical Systems, LLC
Jul 27, 2017	Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part ...	There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo...	Class II	Datascope Corporation
Jul 27, 2017	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK,...	There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo...	Class II	Datascope Corporation
Jul 27, 2017	Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part ...	There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flo...	Class II	Datascope Corporation
Jul 17, 2017	CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b...	False blood back detection alarm and the ingress of fluids into the IABP affecting various electr...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Jul 17, 2017	CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ...	False blood back detection alarm and the ingress of fluids into the IABP affecting various electr...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Jul 17, 2017	CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b...	False blood back detection alarm and the ingress of fluids into the IABP affecting various electr...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017	CS 100 Intra-Aortic Balloon Pump	The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017	CS 100i Intra-Aortic Balloon Pump	The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m...	Class I	Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017	CS 300 Intra-Aortic Balloon Pump	The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m...	Class I	Maquet Datascope Corp - Cardiac Assist Division
May 22, 2017	Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 70106...	55 kits were distributed after their expiration date of September 2015.	Class II	Maquet
Apr 12, 2017	SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & ...	Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION ...	Class II	Datascope Corporation
Jan 27, 2017	VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usag...	Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the d...	Class II	Maquet Cardiovascular, LLC
Jan 25, 2017	SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAI...	DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p...	Class III	DeRoyal Industries Inc
Jan 25, 2017	DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED W...	DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p...	Class III	DeRoyal Industries Inc
Dec 23, 2016	Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Referenc...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 ...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 09...	Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CAR...	Class II	Maquet Datascope Corp - Cardiac Assist Division
Dec 23, 2016	Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-1...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-0...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Refe...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Dec 23, 2016	Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 In...	Chest drains manual vent valve located at the top of affected chest drains could potentially not ...	Class II	Atrium Medical Corporation
Oct 5, 2016	Accessory Adapter Part number 600525A0 Product Usage: designed for the mo...	Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 ...	Class II	Maquet Medical Systems USA
Sep 27, 2016	Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temper...	There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ...	Class II	Maquet Cardiovascular Us Sales, Llc
Aug 12, 2016	The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecti...	Post Market Surveillance cases reported to Maquet showing instances in which the welded joint bet...	Class II	Maquet Cardiovascular Us Sales, Llc
Mar 21, 2016	AngioVac Circuit Pack (Tandem Packs), REF/Catalog No. 25-187, UPN H965251870,...	Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 21, 2016	Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Us...	Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the pr...	Class II	Angiodynamics Inc. (Navilyst Medical Inc.)
Mar 11, 2016	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Specia...	There is a potential problem with the cuvette where failure of the cuvette would cause an error m...	Class III	Datascope Corporation
Mar 11, 2016	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Numb...	There is a potential problem with the cuvette where failure of the cuvette would cause an error m...	Class III	Datascope Corporation
Mar 11, 2016	Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Pa...	There is a potential problem with the cuvette where failure of the cuvette would cause an error m...	Class III	Datascope Corporation
Feb 23, 2016	Custom Tubing Packs Custom tubing pack for oxygenators	Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo...	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016	HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator	Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo...	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016	QUADROX-i oxygenators Custom tubing packs for the oxygenator	Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo...	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 23, 2016	Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator	Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of expo...	Class II	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.