The Recall Desk
HighFDA (Devices)·Z-0647-2021·Announced 2020-12-30

GA Health Company Recalls Bulldog Disposable Endoscope Valves Due to Defects

GA Health Company is recalling 20,000 units of Bulldog Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that may cause prolonged procedures, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

GA Health Company Limited is recalling 20,000 units of Bulldog Disposable Endoscope Valves, including air/water, suction, biopsy, and auxiliary water jet connectors. The recall is due to reports that the suction button is sticky and/or broken during or after procedures, which may cause prolonged procedure times.

The affected product is distributed nationwide in the United States, including in Illinois, New York, New Jersey, Wisconsin, Michigan, and Minnesota. The specific lot numbers are 20B10B and 20G10A. Unit UDIs are 0816734021347, Box UDIs are 10816734021344, and Cartoon Box UDIs are 20816734021341.

Healthcare facilities and consumers should stop using the affected valves and contact GA Health Company Limited for instructions on return or replacement.

The recalled product

Product
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
Affected units
20,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers: 20B10B

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 11 recalled by GA HEALTH COMPANY LIMITED under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →