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.
Read the official notice →- Date
- 2025-11-26
- Country
- United States
- Brand
- Medtronic Perfusion Systems
- Product
- Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
- Classification
- Class II
- Units
- US Nationwide distribution in the states of Hawaii and New York.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-07-01
US
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
US
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 →- 2026-03-04
US
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…
- 2025-11-26
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.
- 2025-09-10
US
Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
The catheters may not retain their shape.
Other drugs & medical recalls in the United States
- 2025-11-26
US
Cellavision AB recalls REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5…
Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
FDA · DeviceCellavision ABUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice →US
Beckman Coulter Inc. recalls DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro…
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY,…Official notice →US
Berkeley Advanced Biomaterials, LLC recalls Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is…
Due to incorrect product label (Incorrect product name identified on outer packaging).
FDA · DeviceBerkeley Advanced Biomaterials, LLCU.S. Nationwide distribution in the state of TN.Official notice →US
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor…
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be…
FDA · DevicePOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCUSA: AK AL,AR,AZ, CA,CO,CT,DC,DE,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice →US
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product…
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
US
Quest International, Inc. recalls Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software…
Due to distributing the measles IgG IVD without a premarket approved/cleared.
FDA · DeviceQuest International, Inc.All products were distributed in the United States. (Utah, Washington).Official notice →