RegWardenFDA facility compliance records
Facility

ERBE MEDICAL, LLC

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2026: 1 recalls20172018201920202021202220232024202512026
  • Recalls (1)

Devices registered here (1)

  • Endoscopic Irrigation/Suction System
    Product code OCX (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500

Recalls & enforcement

  • Class IIOngoing2026-03-31
    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 a…

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ERBE MEDICAL, LLC (FEI 3020712480) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020712480-erbe-medical-llc/

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