Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR — Class II medical device recall Z-2218-2026
Ongoing recall by Medtronic Perfusion Systems, reported 2026-05-27, distributed nationwide. Certain lots of product have the potential for a sterile barrier breach.
| Recall number | Z-2218-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2026-04-21 |
| Classified | 2026-05-20 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CN, CO, CR, CY, DE, DK, ES, FR, GB, HK, HU, IT, JP, KR, LT, LV, MA, MY, NL, NO, PA, PL, RS, RU, SE, SG, TH, TR, TW, UY, VN, ZA |
| Quantity | 2,620 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00643169454736, 00673978188713, 20643169454730 |
| Lot numbers | 0231650787, 0231650793, 0231758250, 0231758255, 0231758279, 0231758282, 0231823523, 0231862812, 0231937422, C231965721, C231966207, C232428221, C232430086 |
| Model numbers | 94725 |
Product
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter
Reason for recall
Certain lots of product have the potential for a sterile barrier breach.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2218-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.