FDA Device recall Z-1621-2025
Guide Wire with Ruler Tube 3x1000 mm DIA
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Guide Wire with Ruler Tube 3x1000 mm DIA by Stryker, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1621-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-28 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker |
| Distribution | US |
Product
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Reason
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.
Identifiers
| code_info | Catalog number/REF: 2351-3100S; UDI-DI: 07613327361803; Lot #: KU164143, KU164755, KU164756, KU164757, KU164758, KU1647…Catalog number/REF: 2351-3100S; UDI-DI: 07613327361803; Lot #: 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, KU165170, KU165171, KU165172, KU165173, KU165174, KU165175, KU184035, KU184036, KU184039, KU184041, KU184042, KU184044, KU184045, KU184046, KU184047, KU184049. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1621-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.