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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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DateProductReasonClassFirm
Feb 18, 2022 Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood ... Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of th... Class II Maquet Medical Systems USA
Feb 9, 2022 Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF ... Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms ma... Class II Maquet Cardiovascular, LLC
Jan 14, 2022 HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 6... Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 ... Class II Maquet Cardiovascular, LLC
Dec 9, 2021 Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the fo... A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) h... Class I Getinge Usa Sales Inc
Dec 1, 2021 Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated... Class II Maquet Cardiovascular, LLC
Jul 14, 2021 Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water ... There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ... Class II Maquet Medical Systems USA
Jan 29, 2021 Anesthesia gas-machine - Product Usage: intended for use in administering ane... Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zer... Class II Getinge Group Logistics America, LLC
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
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Prod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Produ... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemora... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Cod... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, LLC
Apr 7, 2020 HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code... Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding a... Class II Maquet Cardiovascular, 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
Nov 20, 2019 Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is ... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation
Nov 20, 2019 Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It i... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation
Nov 20, 2019 Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an... Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer... Class II Datascope Corporation
Nov 13, 2019 Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane... Sterile barrier system may be compromised Class II GETINGE 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

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.