Reported May 13, 2026 · Ongoing
ERBEFLO CleverCap CO2
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 CleverCap CO2
6 products · 154 lot codes
20325-239Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources
- UDI-DI
04065655000375
85 recalled lot codes
W4464506W4464507W4464512W4464514W4464515W4464516W4464517W4465114W4465115W4465116W4465702W4465709W4465991W4466004W4466266W4466267W4466268W4466269W4466271W4466272W4466273W4466275W4466278W4466279W4466813W4466814W4466815W4466816W4467057W4467058W4467059W4467680W4467681W4468147W4468148W4468273W4468274W4468275WO468776WO468777WO468778WO468779WO468780WO469443WO469444WO469448WO469449WO469450WO469451WO469452WO469933WO469934WO469947WO469948WO469949WO469950WO469951WO469952WO470768WO470774WO470775WO470776WO470777WO470778WO470896WO470897WO470913WO470914WO470915WO470922WO471236WO471237WO471238WO471239WO471240WO471241WO471242WO473987WO473988WO473989WO473991WO475246WO475247WO475248WO475249
20325-240Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR
- UDI-DI
04065655000405
29 recalled lot codes
W4466020W4466021WO468768WO468769WO468770WO468771WO469445WO469446WO469447WO469936WO469937WO471244WO471246WO473170WO473171WO473172WO473173WO473174WO473982WO473983WO473984WO473985WO474409WO474410WO474411WO474412WO474413WO474414WO475243
20325-206Hybrid CO2 Tubing/Cap Set for Olympus Scopes
- UDI-DI
04065655000436
18 recalled lot codes
W4467039W4467049W4467678W4467679WO468582WO470769WO470770WO470771WO470772WO470773WO471076WO471077WO471078WO471079WO471390WO478365WO478366WO478367
20325-207Hybrid CO2 Tubing/Cap Set for Pentax Scopes
- UDI-DI
04065655000689
3 recalled lot codes
W4469939W4469940W4469941
Page 1 of 2
- Amount recalled
- 260,962
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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