🔍 RecallPedia

BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.

Class I - Dangerous
🏥 Medical Devices Recalled: June 26, 2020 Boss Instruments Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383
  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:
Boss Instruments, Ltd.
Reason for Recall:
The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove debris.

Product Codes/Lot Numbers:

Lot Numbers: 00351415,00425391, 00374008,07702195, 08801812, 08802271, 00383211,00384765,00418258, 08804204,09900093, 09900383

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2767-2020