Medline Sprinter OTW — Class II medical device recall Z-1483-2022
Ongoing recall by Medtronic Inc, reported 2022-08-10, distributed nationwide. Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected
| Recall number | Z-1483-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc, Minneapolis, MN, United States |
| Recall initiated | 2022-06-24 |
| Classified | 2022-08-01 |
| Reported by FDA | 2022-08-10 |
| Distributed | Nationwide (US) |
| Quantity | 84 units |
| UPC / GTIN / UDI-DI | 00643169850491 |
| Lot numbers | 222066656 |
| Model numbers | SPR2512W |
| Expiration dates | 2023-04-13 |
Product
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Reason for recall
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
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-1483-2022. 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.