The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1620-2025·Announced 2025-04-23

Guide Wire with Ruler Tube 3x800 mm Metal Ring Detachment Recall

Stryker GmbH is recalling the Guide Wire with Ruler Tube 3x800 mm DIA because the metal ring at the end may detach during surgery. The defect could interfere with the surgical procedure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II medical device recall with a defect that could cause intraoperative complications (metal ring detachment during surgery). The source text does not report any injuries or illnesses, making this a risk-of-harm scenario without reported adverse events, consistent with a High severity classification per the rubric.

Plain-English summary

Stryker GmbH is recalling the Guide Wire with Ruler Tube 3x800 mm DIA (Catalog number/REF: 2351-3080S) because the metal ring at the end of the instrument may detach from the main body during use in surgery. A total of 1,588 units have been distributed nationwide.

The recalled products were distributed across California, Georgia, Illinois, Kentucky, Massachusetts, Maryland, New York, Ohio, Tennessee, Texas, and West Virginia. The affected lot numbers are KU155697 through KU155712. Affected devices can be identified by the UDI-DI: 07613327361797.

Healthcare facilities and providers who have this device in stock should stop using it immediately and contact Stryker GmbH for instructions on returning or replacing affected units.

The recalled product

Product
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Manufacturer
Stryker GmbH
Category
Medical Device — Surgical Instrument
Hazard
Affected units
1,588

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 (18)

  • 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

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Stryker GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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