GA Health Recalls Andorate Disposable Endoscope Valves Due to Suction Button Defect
GA Health Company Limited is recalling 50 units of Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional defect that may prolong procedures, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
GA Health Company Limited is recalling 50 units of the Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus (Product Code: GAR3846). The recall is due to reports that the suction button is sticky and/or broken during or after the procedure, which may cause prolonged procedures.
The affected product was distributed nationwide in the United States, including in the states of Illinois, New York, New Jersey, Wisconsin, Michigan, and Minnesota. The specific lot number is 20031002. Unit UDI is 04897106952571, Box UDI is 14897106952578, and Cartoon Box UDI is 24897106952575.
Healthcare providers and consumers should stop using the affected units and contact GA Health Company Limited for further instructions or a return.
The recalled product
- Product
- Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleaning Adapter Kit for Olympus Product Code: GAR3846
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 50
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
Same manufacturer · GA HEALTH COMPANY LIMITED
See all →- HighGA Health Recalls 10,000 STOPCON Suction Valves for GI Endoscopes
FDA (Devices) · 2020-12-30
- HighGA Health Company Recalls STOPCON Disposable Valves Due to Defects
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- HighGA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button
FDA (Devices) · 2020-12-30
- HighGA Health Recalls ScopeValet Guardian Disposable Endoscope Valves Due to Defect
FDA (Devices) · 2020-12-30
- HighGA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button
FDA (Devices) · 2020-12-30
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