The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1621-2025·Announced 2025-04-23

Guide Wire with Ruler Tube metal ring detachment recall

Stryker GmbH is recalling Guide Wire with Ruler Tube 3x1000 mm DIA devices because the metal ring at the end may detach during surgery.

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: This is an FDA Class II recall involving a risk-of-harm medical device where detachment of a component during surgery could cause patient injury. The source text does not report any illnesses or injuries, but the potential for serious harm during a surgical procedure meets the High criteria for risk-of-harm products.

Plain-English summary

Stryker GmbH is recalling Guide Wire with Ruler Tube 3x1000 mm DIA (Catalog number/REF: 2351-3100S) because the metal ring at the end of the instrument may detach from the main body during use in surgery. This device is a medical instrument used in surgical procedures.

Approximately 6,407 units were distributed nationwide to healthcare facilities in California, Georgia, Illinois, Kentucky, Massachusetts, Maryland, New York, Ohio, Tennessee, Texas, and West Virginia. The affected products are identified by Catalog number 2351-3100S, UDI-DI 07613327361803, and specific lot numbers including KU164143 through KU164783, KU165161 through KU165175, and KU184035 through KU184049.

If you have a device from one of the affected lot numbers, contact Stryker GmbH or your healthcare facility for instructions on inspection, replacement, or proper handling of the affected instrument.

The recalled product

Product
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Manufacturer
Stryker GmbH
Category
Medical Device — Surgical Instrument
Hazard
Affected units
6,407

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.

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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