CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report

Guide Wire with Ruler Tube mm DIA recalled by Stryker

Stryker is recalling Guide Wire with Ruler Tube mm DIA, distributed nationwide in the US. The recall was initiated on 28 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number/REF: 2351-3080S; UDI-DI: 07613327361797; Lot #: KU155697, KU155698, KU155699, KU155700, KU155701, KU155702, KU155703, KU155704, KU155705, KU155706, KU155707, KU155708, KU155709, KU155710, KU155711, KU155712.

Quantity recalled1588 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1620-2025
FDA event ID: 96555
Recalling firm: Stryker, Selzach
Classification: Class II
Status: Ongoing
Recall initiated: 28 Mar 2025
FDA classified: 17 Apr 2025
Reported: 23 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

28 Mar 2025	Recall initiated by company
17 Apr 2025	Classified by FDA	+20 days
23 Apr 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;

Where it was distributed

US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.

Nationwide California Georgia Illinois Kentucky Massachusetts Maryland New York Ohio Tennessee Texas West Virginia

Questions about this recall

Is Guide Wire with Ruler Tube mm DIA recalled?

Yes. Stryker recalled Guide Wire with Ruler Tube mm DIA on 28 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1620-2025.

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.

Which lots are affected?

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.

Where was it sold?

US Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH, TN, TX, WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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