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

ScopeValet Guardian Disposable Endoscope Valves Set recalled

GA Health is recalling ScopeValet Guardian Disposable Endoscope Valves Set, 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: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384

Quantity recalled100,000 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-0648-2021
FDA event ID: 86763
Recalling firm: GA Health, 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 Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1

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

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: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384

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

Other products in this recall event

10 other products · FDA event 86763

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020	CLASS II	Andorate Disposable Endoscope Valves Set-5-piece Valve recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	Stopcon Disposable Endoscope Valves Set-Single Use Valves recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	Andorate Disposable Endoscope Valves Set-Contains Air/Water recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	Andorate Disposable Endoscope Valves Set-Contains Suction recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	Bulldog Disposable Endoscope Valves Set-Air/Water Valve recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	Bulldog Disposable Endoscope Valves Set-Air/Water Valve recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	ScopeValet Guardian Disposable Endoscope Valves Set recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	Stopcon Disposable Valves Set-Single Use Single Use Valves Olympus R recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	Stopcon Suction Valve-Suction Valve for GI-Endoscope recalled	GA Health	Other	Nationwide
30 Dec 2020	CLASS II	Stopcon Disposable Valves Set-Single Use Valves recalled	GA Health	Other	Nationwide

More recalls from GA Health

All 11

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

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide