Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
Class I - DangerousWhat Should You Do?
- Check if you have this product: Material Code MG096R (1.1 CM) MG097R (1.3 CM) MG227 (1.45CM) MG228 (1.6CM) MG229 (2.1 CM) MG230 (2.6CM)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Aesculap Implant Systems LLC
- Reason for Recall:
- Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
Product Codes/Lot Numbers:
Material Code MG096R (1.1 CM) MG097R (1.3 CM) MG227 (1.45CM) MG228 (1.6CM) MG229 (2.1 CM) MG230 (2.6CM)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0947-2017
Related Recalls
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Aesculap Implant Systems
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Aesculap Implant Systems
Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.