FDA Device recall Z-2064-2026
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
- FDA Device
- Class II
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class II recall of ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 by Erbe Medical, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2064-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-31 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Erbe Medical |
| Distribution | US |
Product
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
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.
Identifiers
| code_info | UDI-DI: 04065655000252. Lots: W4465580, W4466022, W4466023, WO469442, WO469923, WO473978, WO473979, WO473980, WO473981, WO476347, WO477013, WO477014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2064-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.