Recall Z-2063-2026— Erbe Medical, LLC

Name: FDA recall Z-2063-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-31

Class II · Ongoing

Class II FDA medical device recall by Erbe Medical, LLC, initiated 2026-03-31. It names one FDA 510(k) clearance: K221177. Product: ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;. Reason: 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..

Recalling firm: Erbe Medical, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-03-31
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K221177 — Erbe's Tubing/Cap SetsErbe USA, Inc.·cleared 2022-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.