Medtronic Bio-Medicus Insertion Kits — Class II medical device recall Z-0003-2022
Ongoing recall by Medtronic Perfusion Systems, reported 2021-10-13, distributed nationwide. There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the
| Recall number | Z-0003-2022 |
|---|---|
| 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 | 2021-09-13 |
| Classified | 2021-10-01 |
| Reported by FDA | 2021-10-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, ES, FR, JP, KR, SA, TR |
| Quantity | 168 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20763000115986, 20763000116006 |
| Serial numbers | 220641720, 220719040 |
| Model numbers | 96551, 96553 |
Product
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Reason for recall
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
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-0003-2022. 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.