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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker Guide Wire with Ruler Tube Recalled for Metal Ring Detachment Risk

Agency Publication Date: April 17, 2025
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Summary

Stryker GmbH has recalled 7,995 Guide Wires with Ruler Tubes because a metal ring at the end of the instrument may detach from the main body during surgery. The recall affects two specific sizes of the device: the 3x800 mm and 3x1000 mm diameter models. While approximately 7,995 units are affected, there have been no reported incidents or injuries to date.

Risk

If the metal ring detaches during a surgical procedure, it could become a foreign object left inside the patient's body or cause delays in the surgery. This poses a risk of internal injury or the need for additional medical procedures to retrieve the detached part.

What You Should Do

  1. This recall affects Stryker Guide Wires with Ruler Tubes sold in 3x800 mm and 3x1000 mm diameter sizes, used in surgical environments.
  2. Check the catalog numbers (2351-3080S or 2351-3100S) and specific lot numbers printed on the device packaging to see if your inventory is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately. Contact Stryker GmbH or your authorized distributor to arrange for the return, replacement, or correction of any affected instruments.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov for additional information regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Guide Wire with Ruler Tube 3x800 mm DIA
Model / REF:
2351-3080S
Lot Numbers:
KU155697
KU155698
KU155699
KU155700
KU155701
KU155702
KU155703
KU155704
KU155705
KU155706
KU155707
KU155708
KU155709
KU155710
KU155711
KU155712
UDI:
07613327361797

Quantity: 1588 units

Product: Guide Wire with Ruler Tube 3x1000 mm DIA
Model / REF:
2351-3100S
Lot Numbers (56):
KU164143
KU164755
KU164756
KU164757
KU164758
KU164759
KU164760
KU164761
KU164762
KU164763
KU164764
KU164765
KU164766
KU164767
KU164768
KU164769
KU164770
KU164771
KU164772
KU164773
KU164774
KU164775
KU164776
KU164777
KU164778
KU164779
KU164780
KU164781
KU164782
KU164783
KU164784
KU165161
KU165162
KU165163
KU165164
KU165165
KU165166
KU165167
KU165168
KU165169
KU165170
KU165171
KU165172
KU165173
KU165174
KU165175
KU184035
KU184036
KU184039
KU184041
UDI:
07613327361803

Quantity: 6407 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96555
Status: Active
Manufacturer: Stryker GmbH
Sold By: Hospitals; Surgical centers
Manufactured In: Switzerland
Units Affected: 2 products (1588 units; 6407 units)
Distributed To: California, Georgia, Illinois, Kentucky, Massachusetts, Maryland, New York, Ohio, Tennessee, Texas, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.