Quick Facts at a Glance
- Recall Date
- April 21, 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
- GTIN 20643169454785, Lot Numbers: 0231757977, 0231757978, 0231757985, 0231758246, 0231758249, 0231758254, 0231758262 +10 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
April 21, 2026
Reported by FDA DEVICE
May 27, 2026
RecallRadar source check
June 3, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Certain lots of product have the potential for a sterile barrier breach.
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 DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter. Reason: Certain lots of product have the potential for a sterile barrier breach.. Classification: Class II. Quantity: 3210 units. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic Of, Morocco, Netherlands, Norway, Panama, Poland, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Suriname, Sweden, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Vietnam.
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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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