Browse Device Recalls

62 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 62 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 62 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 20, 2020	HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/...	The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product...	Class II	Maquet Cardiovascular Us Sales, Llc
Nov 20, 2020	HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product ...	The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product...	Class II	Maquet Cardiovascular Us Sales, Llc
Sep 30, 2020	Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to mo...	The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, ...	Class II	Maquet Cardiovascular Us Sales, Llc
Sep 24, 2020	Yuno II Mobile Operating Table - Product Usage: support and position the pati...	Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts expos...	Class II	Maquet Cardiovascular Us Sales, Llc
Sep 24, 2020	Yuno Mobile Operating Table - Product Usage: Intended for support and positio...	Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts expos...	Class II	Maquet Cardiovascular Us Sales, Llc
Aug 7, 2020	Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: In...	Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This d...	Class III	Maquet Cardiovascular Us Sales, Llc
Jun 18, 2020	Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxy...	Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediat...	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 20, 2020	Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039	A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with...	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 10, 2020	Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and...	Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situ...	Class II	Maquet Cardiovascular Us Sales, Llc
Jan 16, 2020	Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Produ...	Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th...	Class III	Maquet Cardiovascular Us Sales, Llc
Jan 16, 2020	Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Produ...	Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. Th...	Class III	Maquet Cardiovascular Us Sales, Llc
Dec 3, 2019	Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. ...	A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.	Class II	Maquet Cardiovascular Us Sales, Llc
Jul 11, 2019	Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-H...	The sets are configured with quick connectors that have been assembled in reverse on the arterial...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:V...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: V...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:V...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: ...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VL...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: ...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: ...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VL...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: ...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: ...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: ...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: ...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 28, 2019	Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: ...	Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posi...	Class II	Maquet Cardiovascular Us Sales, Llc
May 20, 2019	Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 P...	Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig...	Class II	Maquet Cardiovascular Us Sales, Llc
May 20, 2019	Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Pr...	Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) mig...	Class II	Maquet Cardiovascular Us Sales, Llc
May 6, 2019	GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 ...	User may suffer an electric shock when coming in contact with the exposed electronic components	Class II	Maquet Cardiovascular Us Sales, Llc
Feb 8, 2019	Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardio...	Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled inc...	Class I	Maquet Cardiovascular 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 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
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
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 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
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 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

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.