GA Health recalls Andorate Disposable Endoscope Valves Sets with sticky/broken suction buttons that may cause prolonged procedures. Affected units include specific product codes and lot numbers. Consumers should contact GA Health for details.
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
GA Health is recalling Andorate Disposable Endoscope Valves Sets because the suction button may become sticky or broken during procedures, leading to longer surgery times. This could affect medical staff using the device in endoscopy procedures.
The suction button in the Andorate Disposable Endoscope Valves Set can become sticky or broken during or after medical procedures. This may cause the procedure to take longer than intended, potentially increasing risks for patients and staff.
Medical professionals using endoscopy procedures are most at risk. Patients undergoing endoscopy with this specific valve set may experience longer procedures due to the suction button issue.
Check for product codes GAR046 and lot numbers including 20021025, 20052901, 19102223, 19110721, 19120903, 19120909, 20021046, 20022803, 20030407, 20030408, 20030922, 20030923, 20031802, 20061806. The unit UDI is 04897106950263 and box UDI is 14897106950260.
Identify the product code (GAR046) and lot numbers listed in the recall notice to confirm if your unit is affected.
Reach out to GA Health directly for assistance with the recall process and to determine if your specific unit needs replacement.
The suction button may become sticky or broken during or after procedures, which could cause the procedure to take longer than intended.
Check the product code and lot numbers to see if your unit is affected, then contact GA Health for further instructions.
The recall states the suction button issue may cause prolonged procedures, but it does not mention risks of serious injury or death.
We’ve drafted a message you can send GA Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0644-2021 — GA Health GA Health Hello, I own a GA Health that is covered by recall Z-0644-2021 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.
