Guide Wire with Ruler Tube 3x1000 mm DIA — Class II medical device recall Z-1621-2025
Ongoing recall by Stryker GmbH, reported 2025-04-23, distributed nationwide. The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument du
| Recall number | Z-1621-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker GmbH, Selzach, Switzerland |
| Recall initiated | 2025-03-28 |
| Classified | 2025-04-17 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 6,407 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07613327361803 |
| Lot numbers | KU164143, KU164755, KU164756, KU164757, KU164758, KU164759, KU164760, KU164761, KU164762, KU164763, KU164764, KU164765, KU164766, KU164767, KU164768, KU164769, KU164770, KU164771, KU164772, KU164773, KU164774, KU164775, KU164776, KU164777, KU164778, KU164779, KU164780, KU164781, KU164782, KU164783, KU164784, KU165161, KU165162, KU165163, KU165164, KU165165, KU165166, KU165167, KU165168, KU165169 and 16 more |
| Model numbers | 2351-3100S |
Product
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Reason for recall
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
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-1621-2025. 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.