Recall archive
453 recalls · page 1 of 19
In the agency's Nov 18, 2026 enforcement report
Sheehy VENTILATION TUBE 5PK BUTTON 1.27 FLPL, REF: 1013301, Lot# 0231048279 (GTIN 20763000281636), Lot# 0231048280…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Ventilation tubes, that provide a passageway for movement of air between the auditory canal and the middle ear, were not subjected to the required…
FDA (weekly enforcement report)
In the agency's Nov 18, 2026 enforcement report
CareLink SmartSync Device Manager App, a tablet-based platform used to program and interrogate compatible Medtronic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand · Product · Product details — Bluetooth disconnections may occur between the device manager software and its associated accessories. Bluetooth disconnections during a SmartSync…
2 more products in this recall
FDA (weekly enforcement report)
Reported Nov 4, 2026
OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure"…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand · Product · Product details — Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential…
1 more product in this recall
FDA (weekly enforcement report)
Reported Oct 28, 2026Updated Nov 2, 2026
CareLink Clinic, REF: MMT-7350
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 28, 2026Updated Nov 2, 2026
InterStim SureScan MRI Leads 978A1 & 978B1: LEAD 978A128 ISTM MICRO 28CM SSMRI TINED 978A128 LEAD 978A133 ISTM MICRO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 21, 2026Updated Oct 26, 2026
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Reason for recall — Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
Matched: Product · Product details · Reason for recall — Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in…
FDA (openFDA device enforcement)
Reported Oct 14, 2026Updated Oct 20, 2026
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand · Product details — Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed…
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress,…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 5, 2026
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia,…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 29, 2026
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the…
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Ventriculostomy Kit, REF: 46154
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand — Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed…
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details · Reason for recall — Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2026
Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP
Matched: Reason for recall — Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2026
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering…
FDA (openFDA device enforcement)
Reported Jul 8, 2026
Medtronic Harmony Delivery Catheter System
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Heart Valves Division
Matched: Brand · Product · Product details — Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the…
FDA (openFDA device enforcement)
Reported Jul 1, 2026
Octopus Evolution Tissue Stabilizer, Model TS2000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 24, 2026
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Boxborough
Matched: Brand · Product · Product details — Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
FDA (openFDA device enforcement)
Reported Jun 3, 2026
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 27, 2026
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — Certain lots of product have the potential for a sterile barrier breach.
8 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2026
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged…
FDA (openFDA device enforcement)
Reported May 6, 2026
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic, Inc.
Matched: Brand · Product · Product details · Reason for recall — Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik…
FDA (openFDA device enforcement)
Reported Apr 8, 2026
MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand · Reason for recall — All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and…
13 more products in this recall
FDA (openFDA device enforcement)
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