HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).
- 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:
- Bovie Medical Corporation
- Reason for Recall:
- There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Product Codes/Lot Numbers:
Catalog Numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1154-2021
Related Recalls
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.