Warning
Erbe Medical Recalls ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2063-2026Medical Device
Erbe Medical Recalls ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes
Erbe Medical, LLC · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database