FDA Medical devices recall ·
Guide Wire with Ruler Tube 3x800 mm DIA recall
- Recall number
- Z-1620-2025
- Date
- (initiated March 28, 2025)
- Company / brand
- Stryker GmbH
Bohnackerweg 1, Selzach, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1588 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog number/REF: 2351-3080S; UDI-DI: 07613327361797; Lot #: KU155697, KU155698, KU155699, KU155700, KU155701, KU155702, KU155703, KU155704, KU155705, KU155706, KU155707, KU155708, KU155709, KU155710, KU155711, KU155712.
Distribution
US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.
States: California Georgia Illinois Kentucky Massachusetts Maryland New York Ohio Tennessee Texas West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1620-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.