GA HEALTH COMPANY LIMITED: Medical Device Recall in 2020 - (Recall #: Z-0649-2021)

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:

ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4

Product Classification:

Class II

Date Initiated: November 3, 2020

Date Posted: December 30, 2020

Recall Number: Z-0649-2021

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: 10,000 units

Code Information:

Lot Numbers: 19122419 Unit UDI: 0810929043732 Box UDI: 10810929043739 Carton Box UDI: 20810929041640

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated