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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

Cook Medical Hemospray Endoscopic Hemostat Recalled for Breaking Activation Knob

Agency Publication Date: December 2, 2024
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Summary

Wilson-Cook Medical Inc. is recalling 46 units of the HEMO-7-EU Hemospray Endoscopic Hemostat because the red activation knob can crack or break while the device is being used. This defect is caused by the use of nonconforming raw materials during manufacturing. No incidents or injuries have been reported to date.

Risk

If the activation knob breaks during a medical procedure, the device may fail to deploy, potentially causing a delay in treatment for patients requiring endoscopic hemostasis (stopping of bleeding).

What You Should Do

  1. This recall affects Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat (REF G24663), 2.8 cm, sterile units with UDI-DI 00827002246638.
  2. Identify affected products by checking for the following lot numbers and expiration dates: W4844245 (exp. 6/10/2027), W4847501 (exp. 6/20/2027), and W4851589 (exp. 7/8/2027).
  3. Stop using the recalled device immediately and remove it from clinical inventory.
  4. Contact Wilson-Cook Medical Inc. or your local distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Correction or replacement of affected units.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat
Variants: 2.8 cm, Sterile
Model / REF:
G24663
Lot Numbers:
W4844245 (exp. 6/10/2027)
W4847501 (exp. 6/20/2027)
W4851589 (exp. 7/8/2027)
UDI:
00827002246638

Recall #: Z-0582-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95755
Status: Active
Manufacturer: Wilson-Cook Medical Inc.
Sold By: Medical distributors
Manufactured In: United States
Units Affected: 46 devices

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.