FDA recall, , Moderate risk
Erbe ERBEFLO CleverCap CO2 Tubing and Cap Sets
The Erbeflo CleverCap CO2 Hybrid CO2 Tubing/Cap Set may allow unintended water flow, leading to water aspiration and respiratory failure.
Summary by Recall Canary from the FDA notice
What happened
Erbe Medical, LLC of Tempe, Arizona, recalled Erbeflo CleverCap CO2, Erbeflo 2, and Erbeflo CleverCap devices because a distal irrigation segment connector configuration may be more susceptible to unintended water flow from the distal tip under unsupported third-party connector use, which may lead to water aspiration and progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
The FDA added the recall to its Enforcement Report on May 1, 2026, and the products were distributed nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239;
Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240;
Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206;
Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 20325-207;
ERBEFLO CleverCap Hybrid CO2 Tubing/Cap Set for Fujifilm Scopes, REF: 20325-248;
Hybrid CO2 Tubing/Cap Set for Fujinon Scopes, REF: 20325-208- UDI-DI
- 04065655000375
- 04065655000405
- 04065655000436
- 04065655000689
- 04065655001006
- 04065655001099
- Lot code
- 20325-239
- W4464506
- W4464507
- W4464512
- W4464514
- W4464515
- W4464516
- W4464517
- W4465114
- W4465115
- W4465116
- W4465702
- W4465709
- W4465991
- W4466004
- W4466266
- W4466267
- W4466268
- W4466269
- W4466271
- W4466272
- W4466273
- W4466275
- W4466278
- W4466279
- W4466813
- W4466814
- W4466815
- W4466816
- W4467057
- W4467058
- W4467059
- W4467680
- W4467681
- W4468147
- W4468148
- W4468273
- W4468274
- W4468275
- WO468776
- WO468777
- WO468778
- WO468779
- WO468780
- WO469443
- WO469444
- WO469448
- WO469449
- WO469450
- WO469451
- WO469452
- WO469933
- WO469934
- WO469947
- WO469948
- WO469949
- WO469950
- WO469951
- WO469952
- WO470768
- WO470774
- WO470775
- WO470776
- WO470777
- WO470778
- WO470896
- WO470897
- WO470913
- WO470914
- WO470915
- WO470922
- WO471236
- WO471237
- WO471238
- WO471239
- WO471240
- WO471241
- WO471242
- WO473987
- WO473988
- WO473989
- WO473991
- WO475246
- WO475247
- WO475248
- WO475249
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set
- UDI-DI
- 04065655000252
- Reference number
- 20325-222
- Lot code
- W4465580
- W4466022
- W4466023
- WO469442
- WO469923
- WO473978
- WO473979
- WO473980
- WO473981
- WO476347
- WO477013
- WO477014
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;
- UDI-DI
- 04065655000603
- 04065655001211
- Lot code
- 20325-201
- W4466253
- W4466254
- W4466256
- W4466257
- W4466258
- WO471080
- WO471081
- WO471083
- WO471084
- WO473975
- WO473976
- WO477586
- WO477587
- WO477588
- WO477589
- WO477590
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of IL, NY, CA, WA, UT, KY, PA, TX, AL, OH, FL, IN, NJ, NH, MI, CT, AR, MN, WI, AZ, CO, WV, MT, HI, TN, GA, VA, OK, RI, MO, NM, ID, SC, WY, KS, NC, MS, OR, MD, MA, DE, NE, AK, IA, DC, ME, LA, SD, ND, VT, PR, NV.
- Company
- Erbe Medical, LLCTempe, Arizona
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98674
- Recall numbers
- Z-2062-2026 to Z-2064-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
