FDAClass II · Medical device · Recalled May 27, 2026
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR recall — Medtronic Perfusion Systems
Hazard: Certain lots of product have the potential for a sterile barrier breach.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2222-2026
- Brand
- Medtronic Perfusion Systems
- Classification
- Class II
- Units affected
- 260 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter
Affected products
Companies & origin
- Recalling firm location
- Brooklyn Park, MN, United States
- Firm address
- 7611 Northland Dr N, 55428-1088
Identifying details (verbatim from the notice)
- Product codes / lots
- GTIN 20643169454815, Lot Numbers: 0231665658, C231786900.
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 98786
- Recall initiated
- April 21, 2026
- FDA classified
- May 20, 2026
- FDA report date
- May 27, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.
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