Notice names this product. Erbe Medical’s ERBEFLO 2 is named in FDA Class II recall Z-2064-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: UDI-DI: 04065655000252. Lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014. Units affected: 5,500. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
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 fl…
Company / brand: Erbe Medical recalls
Affected product: ERBEFLO 2 recall status
Official ID Z-2064-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.