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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 Corporation: Portal Entry Kits Recalled Due to Distribution of Expired Product

Agency Publication Date: November 9, 2023
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Summary

Stryker Corporation is recalling 19 Portal Entry Kits (REF: CAT00241) because these medical kits were distributed after they had already expired. Each kit contains essential surgical tools including a skin marker, disposable ruler, two FlexSticks, a 30 ml syringe, and two 17-gauge needles. These kits are used by surgeons to establish arthroscopic portals and joint access during procedures.

Risk

Using expired medical devices can compromise the sterility of the instruments or the integrity of the materials, potentially leading to infections or surgical complications. No specific injuries have been reported to date, but the distribution of expired product is a violation of safety standards.

What You Should Do

  1. Locate your Portal Entry Kit and check the product reference number (REF) for CAT00241.
  2. Check the packaging for Lot Number 007047 and UDI 07613252632863 to determine if your specific kit is affected by this recall.
  3. If you have an affected kit, do not use it in any surgical procedures.
  4. Contact Stryker Corporation directly to arrange for the return of the expired products and to discuss replacement options.
  5. Consult with your healthcare provider if you have concerns regarding a procedure where this kit may have been used.
  6. For further questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Stryker Portal Entry Kit (REF: CAT00241)
Model / REF:
CAT00241
UPC Codes:
07613252632863
Lot Numbers:
007047

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93140
Status: Active
Manufacturer: Stryker Corporation
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 19 kits
Distributed To: New Hampshire, Texas, New York, New Jersey, Ohio, Minnesota

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.