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ERBEFLO CleverCap CO2 Tubing/Cap Sets
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MEDICAL DEVICE RECALLMODERATE

ERBEFLO CleverCap CO2 Tubing/Cap Sets

Erbe Medical recalls ERBEFLO CleverCap CO2 tubing/cap sets due to risk of water aspiration and respiratory failure.

What to do

Stop using the affected ERBEFLO CleverCap CO2 tubing/cap sets immediately. Contact Erbe Medical, LLC for instructions on returning the product and obtaining a replacement or corrective action.

Recalled
Listed
Updated
Recall No.
Z-2062-2026
Agency
FDA
Firm
Erbe Medical, LLC
Recall ID
98674
Status
ONGOING

Why it was recalled

Erbe Medical is recalling ERBEFLO CleverCap CO2 hybrid tubing/cap sets used with endoscopes 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 can lead to water aspiration, aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
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: 20325-208Z-2062-202604065655000375, 04065655000405, 04065655000436, 04065655000689, 04065655001006, 04065655001099
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222Z-2064-202604065655000252
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;Z-2063-202604065655000603, 04065655001211

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification