GA Health ScopeValet Guardian Endoscope Valves Recall: Sticky Suction Button May Cause
GA Health recalls ScopeValet Guardian Disposable Endoscope Valves Sets with sticky/broken suction buttons that may cause prolonged procedures. Affected units include specific product codes and lot numbers.
Use caution until it’s fixed
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Contact the company
What happened, in plain English
GA Health is recalling ScopeValet Guardian Disposable Endoscope Valves Sets because the suction button may become sticky or broken during procedures, leading to longer surgery times. This could delay critical medical treatments and increase patient risk. Read more at govinfonow.com/recall/63985-ga-health-scopevalet-guardian-endoscope-valves-recall-sticky-suction-button.
Source Summary by GovInfoNow · govinfonow.com/recall/63985-ga-health-scopevalet-guardian-endoscope-valves-recall-sticky-suction-button · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0648-2021
Cite this page
“GA Health ScopeValet Guardian Endoscope Valves Recall: Sticky Suction Button May Cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63985-ga-health-scopevalet-guardian-endoscope-valves-recall-sticky-suction-button. Based on FDA recall #Z-0648-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0648-2021%22&limit=1).
Why it’s dangerous
The suction button in the valves may become sticky or broken during or after medical procedures. This can cause the procedure to take longer than intended, potentially delaying critical treatments and increasing patient risk.
Who’s affected
Medical professionals using the ScopeValet Guardian Disposable Endoscope Valves Sets for procedures are most at risk. Patients undergoing surgery with these valves may experience longer procedures due to the suction button issue.
How to tell if you have this one
Check for product code 345SVVO1 and lot numbers 19122414, 20030401, or 20030402. The unit UDI is 0810929040380 and box UDI is 10810929040387.
- Brand
GA Health- Category
Medical device
All 11 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0639-2021 | 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; Lot Numbers: 19121831, 20032007 Unit UDI: 04897106951093 Box UDI: 14897106951090 Carton Box UDI: 24897106951097 | 12,800 units |
| Z-0640-2021 | STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy-valve/auxiliary water connector) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.1; Lot Numbers: 19121830, 20031604 Unit UDI: 04897106951109 Box UDI: 24897106951103 Carton Box UDI: 24897106951103 | 25,000 units |
| Z-0641-2021 | STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2; Lot Numbers: 19121829 Unit UDI: 04897106951116 Box UDI: 14897106951113 Cartoon Box UDI: 24897106951110 | 11,000 units |
| Z-0642-2021 | STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232; Lot Numbers: 19121826 Unit UDI: 04897106951178 Box UDI: 14897106951175 Cartoon Box UDI: 24897106951172 | 10,000 |
| Z-0643-2021 | Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004; Lot Numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503 Unit UDI: 04897106950225 Box UDI: 14897106950222 Cartoon Box UDI: 24897106950229 | 6,470 units |
| Z-0644-2021 | Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046; Lot Numbers: 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806 Unit UDI: 04897106950263 Box UDI: 14897106950260 Cartoon Box UDI: 24897106950267 | 93,700 units |
| Z-0645-2021 | Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846; Lot Numbers: 20031002 Unit UDI: 04897106952571 Box UDI: 14897106952578 Cartoon Box UDI: 24897106952575 | 50 units |
| Z-0646-2021 | Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71; Lot Numbers: 20B10A Unit UDI: 0816734021330 Box UDI: 10816734021337 Cartoon Box UDI: 20816734021334 | 20,000 units |
| Z-0647-2021 | 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; Lot Numbers: 20B10B, 20G10A Unit UDI: 0816734021347 Box UDI: 10816734021344 Cartoon Box UDI: 20816734021341 | 20,000 units |
| Z-0648-2021 | ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1; Lot Numbers: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI: 10810929040387 Carton Box UDI: 20810929040384 | 100,000 units |
| Z-0649-2021 | ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4; Lot Numbers: 19122419 Unit UDI: 0810929043732 Box UDI: 10810929043739 Carton Box UDI: 20810929041640 | 10,000 units |
What to do — step by step
Check Product Details
Verify your ScopeValet Guardian Disposable Endoscope Valves Set has product code 345SVVO1 and lot numbers 19122414, 20030401, or 20030402.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Michigan, Minnesota, New Jersey, New York, Wisconsin.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0648-2021 (November 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0648-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.