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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: Medical Hoods, Needles, and Cannulas Recalled for Distribution After Expiration

Agency Publication Date: July 3, 2024
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Summary

Stryker Corporation has recalled 15 units of specialized medical devices, including the Flyte surgical hood, cement delivery needles, and lesion-directing cannulas, because these products were distributed to customers after their expiration dates. Using expired medical equipment can lead to compromised sterility, material degradation, or reduced device performance during critical medical procedures. These devices were distributed across Arkansas, California, Colorado, Florida, and Michigan. Consumers should immediately identify if they have any of the affected lot numbers and contact Stryker or their healthcare provider for instructions.

Risk

Expired medical devices may no longer be sterile or may fail to perform as intended during surgery or treatment, potentially leading to infections, procedural delays, or ineffective treatment for patients. While no specific injuries were reported, the loss of product integrity due to age poses a moderate risk during invasive procedures.

What You Should Do

  1. Identify if you possess any of the following products and lot numbers: Non-Sterile Flyte Hood (Lot 20040649), Curved Cement Delivery Needle (Lot 6659783), or Sterile Lesion Cannula (Lot 1000388946).
  2. Check your inventory for the specific Catalog Numbers 0408-800-000NS (Hood), 1025-011-500 (Needle), or 0406-630-225 (Cannula) with GTINs 07613327514063, 07613327374629, or 07613327118438.
  3. Immediately stop using any products identified as part of these specific expired lots and quarantine them to prevent clinical use.
  4. Contact your healthcare provider or Stryker Corporation at their Portage, Michigan headquarters to arrange for the return or proper disposal of these expired units.
  5. For additional information or to report a problem, contact the FDA medical device hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: Non-Sterile Flyte Hood
Model / REF:
0408-800-000NS
UPC Codes:
07613327514063
Lot Numbers:
20040649
Product: Curved, Super Elastic Cement Delivery Needle
Model / REF:
1025-011-500
UPC Codes:
07613327374629
Lot Numbers:
6659783
Product: Sterile Cannula with Stylet
Model / REF:
0406-630-225
UPC Codes:
07613327118438
Lot Numbers:
1000388946

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94755
Status: Active
Manufacturer: Stryker Corporation
Sold By: Stryker Corporation
Manufactured In: United States
Units Affected: 3 products (4 units; 3 units; 8 units)
Distributed To: Arkansas, California, Colorado, Florida, Michigan

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.