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
Jan 13, 2026 Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Produ... During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was i... Class II Medtronic Perfusion Systems
Oct 20, 2025 Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 Medtronic personnel observed trace amounts of dry blood on the external carton label and Instruct... Class II Medtronic Perfusion Systems
Oct 3, 2025 MC3 VitalFlow Console, REF 58100; Blood pump of ecmo As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E... Class II Medtronic Perfusion Systems
Sep 12, 2025 Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardi... Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that di... Class II Medtronic Perfusion Systems
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I Medtronic Perfusion Systems
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I Medtronic Perfusion Systems
Aug 6, 2025 DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 121... The catheters may not retain their shape. Class I Medtronic Perfusion Systems
Feb 5, 2025 Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUA... Unexpected loose material in the male luer used in the aortic root cannula has been identified. P... Class I Medtronic Perfusion Systems
Dec 12, 2024 Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr) Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 12, 2024 EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr) Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Dec 12, 2024 DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 770... Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. Class II Medtronic Perfusion Systems
Oct 3, 2024 Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in card... There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Can... Class II Medtronic Perfusion Systems
Jul 9, 2024 Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrect... Class II Medtronic Perfusion Systems
May 16, 2024 TourniKwik Tourniquet Set (CFN 79012) Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Ca... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Clearview Blower/Mister, Model Number 22120 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic I.M.A. Cannulae: DLP¿ 1 mm Arteriotomy Cannula, Model Number 31001 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip,... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic DLP Coronary Ostial Cannulae, Model Number 30050 Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Mode... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt,... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model ... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Mar 19, 2024 Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Mode... Potential for unsealed sterile packing. Class II Medtronic Perfusion Systems
Feb 7, 2024 Medtronic DLP Vessel Cannula, Model Number REF 30000 Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... Class II Medtronic Perfusion Systems
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosur... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Dec 12, 2022 Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with... An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the A... Class II Medtronic Perfusion Systems
Apr 20, 2022 Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is p... Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. Class II Medtronic Perfusion Systems
Oct 12, 2021 Medtronic Custom Perfusion kits, with the following product descriptions and ... Product is labeled as non-pyrogenic but endotoxin testing was not performed. Class II Medtronic Perfusion Systems
Sep 27, 2021 Cardioblate CryoFlex Surgical Ablation Console There is potential for intermittent electrical connectivity between the console and probe. Class II Medtronic Perfusion Systems
Sep 13, 2021 Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion... There was a label mix-up between two model numbers resulting in the incorrect guidewire being con... Class II Medtronic Perfusion Systems
Aug 24, 2021 DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only Potential for a wire protrusion through the left heart vent catheter tip Class II Medtronic Perfusion Systems
Aug 24, 2021 DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only Potential for a wire protrusion through the left heart vent catheter tip Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, St... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY8M63R4, Custom Pack HY8M63R4 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 CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System,... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Ster... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Ste... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion Sys... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion Syst... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion Sy... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. 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.