ERBEFLO CleverCap® 20325-201Recalls & reported problems
Erbe Medical, LLC · Hybrid Tubing/Cap Set for Olympus® Scopes · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 31, 2026Open, Classified
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Z-2063-2026 · Root cause: Component change control · FDA record ↗
Other Endoscopic Irrigation/Suction System devices
- OrcaPod™ SUV-628Boston Scientific Corporation · endoscopic irrigation/suction system79 reports
- 2-piece valve kit (Suction and Air/Water Valve) EN10229.2GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit GAR3846GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- Suction Valve EN10232GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO CleverCap® 20325-203Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- BullDog® 1203-71Diversatek Healthcare, Inc. · Endoscopic Irrigation/Suction System1 recall0 reports
- ERBEFLO® 2 20325-222Erbe Medical, LLC · Endoscopic Irrigation/Suction System1 recall0 reports
- 4-piece valve kit(Suction, Air/Water, Biopsy Valves & Auxiliary Water Connector) EN10229.1GA Health Company Limited · Endoscopic Irrigation/Suction System1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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