FDA Device recall Z-0079-2025
Amingo
- FDA Device
- Class I
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class I recall of Amingo by Datex Ohmeda, citing potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0079-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-07-12 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Datex Ohmeda |
| Distribution | US |
Product
Amingo. OUS only.
Reason
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Identifiers
| code_info | GTIN: 00840682102322. Model Number: 1009-9013-000. All Serial Numbers. Not model or lot specific. All devices of the i…GTIN: 00840682102322. Model Number: 1009-9013-000. All Serial Numbers. Not model or lot specific. All devices of the indicated products configured with the AGCO option are potentially affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0079-2025%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.