Browse Device Recalls
1,730 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,730 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 1,730 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 13, 2026 | MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... | Class II | Medtronic MiniMed, Inc. |
| Jul 13, 2026 | MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... | Class II | Medtronic MiniMed, Inc. |
| Jul 13, 2026 | MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damag... | Class II | Medtronic MiniMed, Inc. |
| Jun 24, 2026 | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with c... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with c... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary ... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass a... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 17, 2026 | Ventriculostomy Kit, REF: 46154 | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular... | Class II | Medtronic Neurosurgery |
| Jun 16, 2026 | MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) | For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and misse... | Class II | Medtronic MiniMed, Inc. |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; ... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 28, 2026 | Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP... | Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medt... | Class II | Medline Industries, LP |
| May 27, 2026 | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circ... | Class II | Medtronic MiniMed, Inc. |
| May 25, 2026 | Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010;... | Medtronic received two complaints of loose foreign material confirmed as containing trace levels ... | Class II | Medtronic Perfusion Systems |
| May 25, 2026 | Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardio... | Medtronic received two complaints of loose foreign material confirmed as containing trace levels ... | Class II | Medtronic Perfusion Systems |
| May 22, 2026 | Medtronic Harmony Delivery Catheter System | Devices containing inner shaft assemblies from specific manufacturing lots may have an increased ... | Class I | Medtronic Heart Valves Division |
| May 19, 2026 | Medtronic O-arm O2 Imaging System. Model Number: BI70002000. | Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector pane... | Class II | Medtronic Navigation, Inc.-Boxborough |
| May 13, 2026 | Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... | Class II | Medtronic Neuromodulation |
| May 13, 2026 | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... | Class II | Medtronic Neuromodulation |
| May 12, 2026 | Octopus Evolution Tissue Stabilizer, Model TS2000 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... | Class II | Medtronic Perfusion Systems |
| May 12, 2026 | Octopus 4 Tissue Stabilizer, Model 29400 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... | Class II | Medtronic Perfusion Systems |
| May 12, 2026 | Octopus Evolution AS Tissue Stabilizer, Model TS2500 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... | Class II | Medtronic Perfusion Systems |
| 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 |
| Apr 10, 2026 | Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLO... | Incomplete seals on sterile product | Class II | Stryker Sustainability Solutions |
| Apr 8, 2026 | Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software ... | Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode,... | Class II | Medtronic Neuromodulation |
| Mar 11, 2026 | Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, ... | ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 cath... | Class II | Medtronic, Inc. |
| Feb 13, 2026 | MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, ... | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 530G Insulin Pump (MMT-551, MMT-751) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm Insulin Pump (MMT-712, MMT-715) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 620G Insulin Pump (MMT-1750) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
| Feb 13, 2026 | MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found... | Class II | Medtronic MiniMed, Inc. |
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.