Z-2063-2026Class II

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

Name: Z-2063-2026 ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap...
Creator: Erbe Medical, LLC
Published: 2026-03-31
License: https://open.fda.gov/license/

Erbe Medical, LLC / initiated 2026-03-31 / Open, Classified / root cause: sterility

FDA source

Erbe Medical, LLC began a recall of ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203 on 2026-03-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2063-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-31
Posted: 2026-05-01
Recalling firm: 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;
Product code: OCX Endoscopic Irrigation/Suction System
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.
Root cause tag: sterility
FDA root cause: Component change control
Action: On 3/31/2026, correction notices were emailed to Medical Directors, Risk Managers, Medical Device Safety Officers, or Healthcare Professionals informing them to take the following actions: 1) Discontinue use of unsupported third-party Scope Port Connectors. 2) Provide this notice to all personnel within your organization who use, service, purchase, stock, or otherwise manage. 3) If you further distributed any affected devices, promptly forward this notice to those accounts and request that they take the same actions. 4) Continue following the instructions for use, including verifying connector compatibility, ensuring that all connectors are fully seated, confirming that all joints and interfaces are secure, and verifying correct placement and alignment of the tubing within the pump head. 5) Utilize the compatibility table in the notice until updated Notes on Use is received. 6) Complete and return the response form via email to [email protected]. Firm contacts: Correction: [email protected], 480-564-1899. Routine Customer Service and Complaints: [email protected], 1-800-778-3723
Quantity in commerce: 23,359
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2063-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2062-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-2063-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01
Z-2064-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-13	2026-05-01

Product code OCX

K221177Class IIErbe's Tubing/Cap SetsErbe USA, Inc. / cleared 2022-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)