GA Health recalls Andorate Disposable Endoscope Valves Set (Product Code GAR004) due to sticky/broken suction button causing prolonged procedures. Affected units include specific lot numbers and UDI codes.
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 use, leading to longer procedures. This could affect medical procedures where quick adjustments are needed.
The suction button in the device can become sticky or broken during or after a procedure. This may cause the procedure to take longer than intended, potentially delaying critical medical care.
Medical professionals using the Andorate Disposable Endoscope Valves Set during procedures are most at risk. Patients undergoing procedures with this device may experience longer treatment times.
Check the product code (GAR004) and lot numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503. The unit UDI is 04897106950225 and box UDI is 14897106950222.
Verify the product code (GAR004) and lot numbers listed in the recall notice.
The suction button may become sticky or broken during or after procedures, causing prolonged treatment times.
The recall notice does not specify a remedy, so check the product details to see if it is affected.
Check the product code (GAR004) and lot numbers: 20040201, 20081925, 19111119, 20021928, 20022682, 20022678, 20030406, 20032503.
We’ve drafted a message you can send GA Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0643-2021 — GA Health GA Health Hello, I own a GA Health that is covered by recall Z-0643-2021 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.
