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ERBEFLO AeroRinse®
Erbe Medical, LLC · Model 20325-237 · UDI-DI 04065655001068
FEQ
Prescription
1
510(k) clearances
1,316
Adverse events (2 deaths)
5
Recalls
46
Facilities
Description
CO2 and Water Tubing/Cap Set for Fujinon® Scopes
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-31 | Erbe Medical, LLC | 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 fl |
| 2024-08-23 | Olympus Corporation of the Americas | During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure. |
| 2015-09-11 | Olympus Corporation of the Americas | small puncture marks in a sterile package for an accessory to an Olympus device |
| 2013-05-20 | Olympus America Inc. | There is a possibility that the pump head was not shipped in the locked position. If the pump head is in an unlocked position this may, under certain circumstances, cause the pump |
| 2011-12-12 | Olympus America Inc. | Water may leak from the irrigation tubing used on the Olympus Flushing Pump |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.