Erbe Medical, LLC recalls ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes

Recalling company

Erbe Medical, LLC

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Mar 31, 2026

Reported

May 13, 2026

Distribution

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.

Status

Ongoing

Quantity

23,359

Lot / codes

REF/UDI-DI/Lots: 20325-201/04065655000603/W4466253, W4466254, W4466256, W4466257, W4466258, WO471080, WO471081, WO471083, WO471084, WO473975, WO473976, WO477586, WO477587, WO477588, WO477589, WO477590; 20325-203/04065655001211/WO473986

Company location

Tempe, AZ

Recall type

Voluntary: Firm initiated

Recall number

Z-2063-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2063-2026 in the FDA Enforcement Report. Also see FDA recall press releases.