GA Health Recalls 10,000 STOPCON Suction Valves for GI Endoscopes
GA Health Company Limited is recalling 10,000 STOPCON Suction Valves for GI endoscopes because the suction button is reported sticky or broken, which may cause prolonged procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 cause prolonged 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 10,000 units of the STOPCON Suction Valve for GI-Endoscope. The product is distributed by Key Surgical in Eden Prairie, Minnesota, and was distributed nationwide in the United States, including in Illinois, New York, New Jersey, Wisconsin, Michigan, and Minnesota.
The recall was initiated because the suction button is reported to be sticky and/or broken during or after the procedure. This defect may cause the procedure to be prolonged.
The affected lot number is 19121826. The Unit UDI is 04897106951178, the Box UDI is 14897106951175, and the Cartoon Box UDI is 24897106951172. Healthcare providers and consumers should check their inventory for these specific identifiers and contact the recalling firm for further instructions.
The recalled product
- Product
- STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 10,000
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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- HighGA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button
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- HighGA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button
FDA (Devices) · 2020-12-30
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