GA Health Recalls 11,000 Stopcon Disposable Endoscope Valve Sets
GA Health Company Limited is recalling 11,000 Stopcon Disposable Endoscope Valve Sets because the suction button may be sticky or broken, potentially prolonging medical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect that may prolong medical procedures, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
GA Health Company Limited is recalling 11,000 units of Stopcon Disposable Endoscope Valve Sets (Product Code: EN10229.2). These single-use valves are distributed by Key Surgical and are intended for use with Olympus endoscopes for air, water, and suction functions.
The recall was initiated because the suction button on the valves is reported to be sticky and/or broken during or after a procedure. This defect may cause the medical procedure to be prolonged. The affected units were distributed nationwide in the United States, including in Illinois, New York, New Jersey, Wisconsin, Michigan, and Minnesota.
Healthcare facilities and consumers should stop using these valves immediately. The specific lot number is 19121829. Users can verify the product using the Unit UDI 04897106951116, Box UDI 14897106951113, or Cartoon Box UDI 24897106951110. For more information, contact the recalling firm or the FDA.
The recalled product
- Product
- 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
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 11,000
Distribution
Part of a larger recall action
This product is one of 11 recalled by GA HEALTH COMPANY LIMITED under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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