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Home › FDA recalls › Medtronic DLP Retrograde Cannula Manual-Inflate Silicone
CLASS II · ModerateFDA

Medtronic Perfusion Systems recalls Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR

📅 Apr 21, 2026 · 📍 Nationwide
Recalling company
Medtronic Perfusion Systems
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter
Reason
Certain lots of product have the potential for a sterile barrier breach.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 21, 2026
Reported
May 27, 2026
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.
Status
Ongoing
Quantity
280 units
Lot / codes
GTIN 20643169454808, Lot Numbers: 0231859673.
Company location
Brooklyn Park, MN
Recall type
Voluntary: Firm initiated
Recall number
Z-2221-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2221-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.