FDAClass II · Medical device · Recall Z-2221-2026 · Recalled May 27, 2026

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

Agency report date: May 27, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR
Company / brand: Medtronic Perfusion Systems
Lot / serial / date codes: GTIN 20643169454808, Lot Numbers: 0231859673.
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.

Agency product description and boundaries

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Certain lots of product have the potential for a sterile barrier breach.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2221-2026
Brand: Medtronic Perfusion Systems
Classification: Class II
Units affected: 280 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR

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 20643169454808, Lot Numbers: 0231859673.
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

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved August 25, 2026 at 6:00 PM UTC.

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