Quick Facts at a Glance
- Recall Date
- May 25, 2026
- Hazard Level
- HIGH
- Brand
- Medtronic Perfusion Systems
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic Perfusion Systems
- Model numbers
- MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 25, 2026
Reported by FDA DEVICE
July 22, 2026
RecallRadar source check
July 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Perfusion Systems or your healthcare provider for instructions. Notification method: Letter
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Full Description
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascular cannula. Reason: Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.. Classification: Class II. Distribution: Worldwide - US Nationwide distribution in the states of MD, CA, MI, WA, PA, NC, FL, AR.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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