🔍 RecallPedia

FMsealer Open Shears. Model FM3001

Class I - Dangerous
🏥 Medical Devices Recalled: October 24, 2016 Domain Surgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Domain Surgical, Inc.
Reason for Recall:
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

FMsealer Open Shears. Model FM3001

Product Codes/Lot Numbers:

Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0690-2017