Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model/REF Number: 5863050. UDI-DI: B33158630500. Lot Number: M28186. Serial Numbers: 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059
- 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:
- Silex Medical, LLC
- Reason for Recall:
- Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
Product Codes/Lot Numbers:
Model/REF Number: 5863050. UDI-DI: B33158630500. Lot Number: M28186. Serial Numbers: 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1898-2025
Related Recalls
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.