CLASS II Device recall · Reported 30 Dec 2020 · FDA Enforcement Report
Bulldog Disposable Endoscope Valves Set-Air/Water Valve recalled
GA Health is recalling Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve, distributed nationwide in the US. The recall was initiated on 3 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0647-2021
- FDA event ID
- 86763
- Recalling firm
- GA Health, Shatin N.T., N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2020
- FDA classified
- 18 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 3 Nov 2020 | Recall initiated by company | |
| 18 Dec 2020 | Classified by FDA | +45 days |
| 30 Dec 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Product as listed by the FDA
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
Where it was distributed
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
Nationwide IllinoisMichiganMinnesotaNew JerseyNew YorkWisconsin
Questions about this recall
Why was it recalled?
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Which lots are affected?
Lot Numbers: 20B10B, 20G10A Unit UDI: 0816734021347 Box UDI: 10816734021344 Cartoon Box UDI: 20816734021341
Where was it sold?
US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 86763This product is part of a recall event; the main page for the event is ScopeValet Guardian Disposable Endoscope Valves Set recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ScopeValet Guardian Disposable Endoscope Valves Set recalled | GA Health | Other | Nationwide | |
| CLASS II | Andorate Disposable Endoscope Valves Set-5-piece Valve recalled | GA Health | Other | Nationwide | |
| CLASS II | Stopcon Disposable Endoscope Valves Set-Single Use Valves recalled | GA Health | Other | Nationwide | |
| CLASS II | Andorate Disposable Endoscope Valves Set-Contains Air/Water recalled | GA Health | Other | Nationwide | |
| CLASS II | Andorate Disposable Endoscope Valves Set-Contains Suction recalled | GA Health | Other | Nationwide | |
| CLASS II | Bulldog Disposable Endoscope Valves Set-Air/Water Valve recalled | GA Health | Other | Nationwide | |
| CLASS II | ScopeValet Guardian Disposable Endoscope Valves Set recalled | GA Health | Other | Nationwide | |
| CLASS II | Stopcon Disposable Valves Set-Single Use Single Use Valves Olympus R recalled | GA Health | Other | Nationwide | |
| CLASS II | Stopcon Suction Valve-Suction Valve for GI-Endoscope recalled | GA Health | Other | Nationwide | |
| CLASS II | Stopcon Disposable Valves Set-Single Use Valves recalled | GA Health | Other | Nationwide |
More recalls from GA Health
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stopcon Disposable Valves Set-Single Use Valves recalled | GA Health | Other | Nationwide |
| Device | CLASS II | Stopcon Suction Valve-Suction Valve for GI-Endoscope recalled | GA Health | Other | Nationwide |
| Device | CLASS II | Stopcon Disposable Valves Set-Single Use Single Use Valves Olympus R recalled | GA Health | Other | Nationwide |
| Device | CLASS II | ScopeValet Guardian Disposable Endoscope Valves Set recalled | GA Health | Other | Nationwide |
| Device | CLASS II | Bulldog Disposable Endoscope Valves Set-Air/Water Valve recalled | GA Health | Other | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |