Medtronic Perfusion Systems recalls Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the…
Read the official notice →- Date
- 2026-03-04
- Country
- United States
- Brand
- Medtronic Perfusion Systems
- Product
- Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
- Classification
- Class II
- Units
- US Nationwide. Global Distribution.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic Perfusion Systems recalls
- 2026-07-22
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Medtronic Perfusion Systems recalls Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
FDA · DeviceMedtronic Perfusion SystemsWorldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA,…Official notice →- 2026-07-01
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Medtronic Perfusion Systems recalls Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached…
- 2026-05-27
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Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Certain lots of product have the potential for a sterile barrier breach.
FDA · DeviceMedtronic Perfusion SystemsWorldwide distribution - US Nationwide and the countries of Australia,…Official notice →- 2025-11-26
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Medtronic Perfusion Systems recalls 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 Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
FDA · DeviceMedtronic Perfusion SystemsUS Nationwide distribution in the states of Hawaii and New York.Official notice →US
Medtronic Perfusion Systems recalls MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go…
- 2025-11-19
US
Medtronic Perfusion Systems recalls Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Other drugs & medical recalls in the United States
- 2026-03-11
US
US
- 2026-03-04
US
Remel, Inc recalls Campy CVA Medium 100/PK, R01272
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
FDA · DeviceRemel, IncUS Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.Official notice →US
Agiliti Health - Ellis recalls Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt…
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10…
US
Medline Industries, LP recalls Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified…
US
Edermy LLC recalls PIE PAK Models: P2HC-A, P2HC-S, P2HC
Lack of 510K clearance
FDA · DeviceEdermy LLCUS Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA,…Official notice →