GA HEALTH COMPANY LIMITED: Medical Device Recall in 2020 - (Recall #: Z-0646-2021)

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:

Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71

Product Classification:

Class II

Date Initiated: November 3, 2020
Date Posted: December 30, 2020
Recall Number: Z-0646-2021
Event ID: 86763
Reason for Recall:

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

Status: Terminated
Product Quantity: 20,000 units
Code Information:

Lot Numbers: 20B10A Unit UDI: 0816734021330 Box UDI: 10816734021337 Cartoon Box UDI: 20816734021334

Distribution Pattern:

US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.

Voluntary or Mandated:

Voluntary: Firm initiated