Protege GPS Self-Expanding Peripheral Stent System — Class II medical device recall Z-0623-2024
Completed recall by Medtronic Inc., reported 2024-01-10, distributed nationwide. Seal defects could compromise the ability of the product packaging to maintain sterility.
| Recall number | Z-0623-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Plymouth, MN, United States |
| Recall initiated | 2023-11-20 |
| Classified | 2024-01-02 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00643169728974 |
| Lot numbers | B644679 |
Product
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Reason for recall
Seal defects could compromise the ability of the product packaging to maintain sterility.
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-0623-2024. 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.