stryker 3 — Class II medical device recall Z-0982-2025
Ongoing recall by Stryker Corporation, reported 2025-01-29, distributed nationwide. There is potential the device inside the package may not match the product information on the outer label (e.g
| Recall number | Z-0982-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2023-06-28 |
| Classified | 2025-01-17 |
| Reported by FDA | 2025-01-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, NL, NZ |
| Quantity | 1,489 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613154028177 |
| Lot numbers | 22160017, 22179027, 22179047 |
| Model numbers | 5820-107-530 |
Product
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Reason for recall
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
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-0982-2025. 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.