Browse Device Recalls
105 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 105 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 105 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 21, 2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Mode... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Mo... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| Apr 21, 2026 | Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model... | Certain lots of product have the potential for a sterile barrier breach. | Class II | Medtronic Perfusion Systems |
| 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 |
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.