GA Health Company recalls STOPCON Disposable Endoscope Valves due to suction button issues that may cause prolonged procedures. 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 Company is recalling STOPCON Disposable Endoscope Valves because the suction button may become sticky or broken during procedures, leading to longer surgery times. This affects medical professionals using the valves in endoscopic procedures.
The suction button in these valves may become sticky or broken during or after procedures. This can cause the procedure to take longer than intended, potentially increasing risks for patients and staff.
Medical professionals using the STOPCON Disposable Endoscope Valves for endoscopic procedures are most at risk. The recall applies to specific product codes and lot numbers distributed by Key Surgical.
Check for product code EN10229.2 and lot numbers starting with 19121829. The valves were distributed by Key Surgical and sold in the U.S. with specific unit and box UDI numbers.
Verify your unit has product code EN10229.2 and lot number starting with 19121829.
The suction button may become sticky or broken during or after procedures, causing prolonged surgery times.
Check for product code EN10229.2 and lot numbers starting with 19121829. The valves were distributed by Key Surgical.
The recall record does not specify a remedy, so contact GA Health Company for guidance.
We’ve drafted a message you can send GA Health Company to request your refund or repair — edit it as you like.
Subject: Recall Z-0641-2021 — GA Health Company GA Health Company Hello, I own a GA Health Company that is covered by recall Z-0641-2021 from GA Health Company. 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.
