Reported May 13, 2026 · Ongoing
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Erbe Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Erbe Medical, LLC · 405 W Geneva Dr · Tempe, AZ · 85282-2003
Is this the product you have?
- ERBEFLO 2, Endoscopy Pump Tubing/Cap Set
- REF20325-222
- Lot codes and dates
- UDI-DI04065655000252
- Lots
W4465580W4466022W4466023WO469442WO469923WO473978WO473979WO473980WO473981WO476347WO477013WO477014
- Amount recalled
- 5,500
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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