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Recall archive

94,355 stored notices, from Jun 20, 2012 to Sep 23, 2026.

444 recalls · page 1 of 19

Medical devices

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: BrandLoaner 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)

Medical devices

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: BrandPinhole 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)

Medical devices

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: BrandFor 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)

Medical devices

Reported Jul 29, 2026

Ventriculostomy Kit, REF: 46154

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Neurosurgery

Matched: BrandVentriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed…

FDA (openFDA device enforcement)

Medical devices

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 recallMedtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

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 recallConvenience 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)

Medical devices

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: BrandA 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)

Medical devices

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 detailsDevices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the…

FDA (openFDA device enforcement)

Medical devices

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 recallDuring 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)

Medical devices

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 detailsPotential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

FDA (openFDA device enforcement)

Medical devices

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 detailsA 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)

Medical devices

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 detailsCertain lots of product have the potential for a sterile barrier breach.

8 more products in this recall

FDA (openFDA device enforcement)

Medical devices

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 detailsSoftware 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)

Medical devices

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 recallVentricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik…

FDA (openFDA device enforcement)

Medical devices

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 recallAll 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)

Medical devices

Reported Apr 1, 2026

MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed, Inc.

Matched: BrandThree software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions…

FDA (openFDA device enforcement)

Medical devices

Reported Mar 4, 2026

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Perfusion Systems

Matched: Brand · Reason for recallDuring the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached…

FDA (openFDA device enforcement)

Medical devices

Reported Feb 18, 2026

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Alphatec Spine, Inc.

Matched: Product detailsDue a design issue where the navigated array connection geometry is incorrect.

1 more product in this recall

FDA (openFDA device enforcement)

Medical devices

Reported Feb 11, 2026

MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed, Inc.

Matched: BrandA software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting…

FDA (openFDA device enforcement)

Medical devices

Reported Jan 21, 2026

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Inc.

Matched: BrandStents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may…

FDA (openFDA device enforcement)

Medical devices

Reported Jan 21, 2026

A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Neuromodulation

Matched: BrandComplaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical…

FDA (openFDA device enforcement)

Medical devices

Reported Dec 31, 2025

Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic Neuromodulation

Matched: BrandSoftware issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume…

FDA (openFDA device enforcement)

Medical devices

Reported Dec 24, 2025

InPen App, Model/CFN Number: MMT-8061 (Android Users)

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Medtronic MiniMed, Inc.

Matched: BrandWhen app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't…

FDA (openFDA device enforcement)

Medical devices

Reported Dec 24, 2025

Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012;…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Seaspine Orthopedics Corporation

Matched: Reason for recallThe NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards…

FDA (openFDA device enforcement)

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