GA Health recalls ScopeValet Guardian Disposable Endoscope Valves Sets with sticky/broken suction buttons that may cause prolonged procedures during medical use. Affected units have specific product codes and lot numbers.
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
GA Health is recalling ScopeValet Guardian Disposable Endoscope Valves Sets because the suction button may become sticky or broken during procedures, potentially causing longer surgery times. This affects medical professionals using the product for endoscopic procedures.
The suction button in these endoscope valves can become sticky or broken during or after medical procedures. This may cause the procedure to take longer than necessary, increasing the risk of complications for patients.
Medical professionals who use the ScopeValet Guardian Disposable Endoscope Valves Sets for endoscopic procedures are most at risk. The recall applies to specific product codes and lot numbers sold to healthcare facilities.
Check the product code (345SVVO4) and lot numbers (19122419) on the packaging. The unit UDI is 0810929043732 and the box UDI is 108109:9043739.
Verify the product code (345SVVO4) and lot number (19122419) on the packaging to confirm if your unit is affected.
The suction button may become sticky or broken during procedures, potentially causing prolonged surgery times.
The recall does not specify a remedy, so check the product code and lot numbers to confirm if your unit is affected.
Look for product code 345SVVO4 and lot number 19122419 on the packaging. The unit UDI is 0810929043732 and the box UDI is 10810929043739.
We’ve drafted a message you can send GA Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0649-2021 — GA Health GA Health Hello, I own a GA Health that is covered by recall Z-0649-2021 from GA Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.