Boss Instruments, Ltd.: Medical Device Recall in 2020 - (Recall #: Z-2767-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: June 26, 2020

Date Posted: August 12, 2020

Recall Number: Z-2767-2020

Event ID: 86040

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.

Status: Terminated

Product Quantity: 96 devices

Code Information:

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

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of CA, TN, TX and the countries of England, Japan, New Zealand, South Africa, South Korea, Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated