GA HEALTH COMPANY LIMITED: Medical Device Recall in 2020 - (Recall #: Z-0639-2021)

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:

STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229

Product Classification:

Class II

Date Initiated: November 3, 2020

Date Posted: December 30, 2020

Recall Number: Z-0639-2021

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: 12,800 units

Code Information:

Lot Numbers: 19121831, 20032007 Unit UDI: 04897106951093 Box UDI: 14897106951090 Carton Box UDI: 24897106951097

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated