[pending] Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Pending LLM rewrite. Source: FDA_DEVICE Z-1621-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
- Manufacturer
- Stryker GmbH
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27