CLASS II Device recall · Reported 30 Dec 2020 · FDA Enforcement Report

ScopeValet Guardian Disposable Endoscope Valves Set recalled

Ga Health Company is recalling ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, distributed nationwide in the US. The recall was initiated on 3 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 19122419 Unit UDI: 0810929043732 Box UDI: 10810929043739 Carton Box UDI: 20810929041640

Quantity recalled10,000 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0649-2021
FDA event ID: 86763
Recalling firm: Ga Health Company, Shatin N.T., N/A
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2020
FDA classified: 18 Dec 2020
Reported: 30 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

3 Nov 2020	Recall initiated by company
18 Dec 2020	Classified by FDA	+45 days
30 Dec 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Illinois Michigan Minnesota New Jersey New York Wisconsin

Questions about this recall

Is ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve recalled?

Yes. Ga Health Company recalled ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve on 3 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0649-2021.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ga Health Company

All 11

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020Device	CLASS II	Stopcon Disposable Valves Set-Single Use Valves recalled	Ga Health Company	Other	Nationwide
30 Dec 2020Device	CLASS II	Stopcon Suction Valve-Suction Valve for GI-Endoscope recalled	Ga Health Company	Other	Nationwide
30 Dec 2020Device	CLASS II	Stopcon Disposable Valves Set-Single Use Single Use Valves Olympus R recalled	Ga Health Company	Other	Nationwide
30 Dec 2020Device	CLASS II	Bulldog Disposable Endoscope Valves Set-Air/Water Valve recalled	Ga Health Company	Other	Nationwide
30 Dec 2020Device	CLASS II	Bulldog Disposable Endoscope Valves Set-Air/Water Valve recalled	Ga Health Company	Other	Nationwide

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