GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button
GA Health Company Limited is recalling 93,700 units of Andorate Disposable Endoscope Valves 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 in a medical device that may prolong 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 93,700 units of Andorate Disposable Endoscope Valves (Product Code: GAR0446). The recall involves specific lot numbers and distribution across the United States, including Illinois, New York, New Jersey, Wisconsin, Michigan, and Minnesota.
The recall was initiated because the suction button on the valves is reported to be sticky and/or broken during or after the procedure. This defect may cause the medical procedure to be prolonged. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and consumers who possess these products should stop using them and contact the recalling firm for instructions on return or replacement. The affected product codes and lot numbers are listed in the official recall notice.
The recalled product
- Product
- Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy Valves and Auxiliary Water Connector Product Code: GAR046
- Manufacturer
- GA HEALTH COMPANY LIMITED
- Affected units
- 93,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lot Numbers: 20021025
- 20052901
- 19102223
- 19110721
- 19120903
- 19120909
- 20021046
- 20022803
- 20030407
- 20030408
- 20030922
- 20030923
- 20031802
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
- ModerateGA Health Recalls Andorate Disposable Endoscope Valves Due to Suction Button Defect
FDA (Devices) · 2020-12-30
- HighGA Health Company Recalls STOPCON Disposable Valves Due to Defects
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
Same hazard · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12