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Browse Device Recalls

96 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 96 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 96 FDA device recalls.

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DateProductReasonClassFirm
Apr 29, 2021 Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion Sys... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfu... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion Sys... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Cust... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion Sy... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion Sy... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System,... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Mar 3, 2021 Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers... An electrical component within the system controller module of certain Bio-Console 560 devices ma... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reserv... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Card... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Af... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). ... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Feb 4, 2021 Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION... Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... Class I Medtronic Perfusion Systems
Nov 14, 2019 Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in t... Class II Medtronic Perfusion Systems
Nov 27, 2018 RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation ... Medtronic discovered that certain Y-connectors included in the suction lines have exhibited teari... Class II Medtronic Perfusion Systems
Nov 27, 2018 SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Antic... Medtronic discovered that certain Y-connectors included in the suction lines have exhibited teari... Class II Medtronic Perfusion Systems
Aug 8, 2018 Extra corporeal circuit with bio-active surface. Affected products failed a sterilization test. Class II Medtronic Perfusion Systems
Feb 8, 2018 BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage... Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and... Class II Medtronic Perfusion Systems
Jan 16, 2018 Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter... Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alo... Class II Medtronic Perfusion Systems
Jan 16, 2018 Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 ... Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alo... Class II Medtronic Perfusion Systems
Jan 3, 2018 Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal c... Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lac... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Extension Line Adapters 20 in length Used to extend cardioplegia line du... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure m... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia altern... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Jun 22, 2017 DLP Pressure Disposable Pressure Display Sets Extends the pressure line in o... Identification of small pinholes in a single packaging configuration of sterile pouches. A total... Class II Medtronic Perfusion Systems
Feb 4, 2016 Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu... Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub... Class III Medtronic Perfusion Systems
Oct 28, 2015 Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Ste... This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactu... Class II Medtronic Perfusion Systems
Aug 18, 2015 MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist ... Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... Class II Medtronic Perfusion Systems
Aug 18, 2015 MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators... Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... Class II Medtronic Perfusion Systems
Jul 24, 2015 Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to... EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. Class II Medtronic Perfusion Systems
Jun 12, 2015 Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and D... Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports ... Class II Medtronic Perfusion Systems
Oct 31, 2014 The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bi... Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenat... Class II Medtronic Perfusion Systems

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.