Anesthesia gas-machine — Class II medical device recall Z-1181-2021
Terminated recall by Getinge Group Logistics America, LLC, reported 2021-03-17, distributed nationwide. Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected
| Recall number | Z-1181-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Group Logistics America, LLC, Wayne, NJ, United States |
| Recall initiated | 2021-01-29 |
| Classified | 2021-03-05 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2023-09-28 |
| Distributed | Nationwide (US) |
| Quantity | 144 units |
| UPC / GTIN / UDI-DI | 07325710001318, 07325710001349, 07325710009765 |
| Serial numbers | 1058, 1059, 1060, 1167, 1169, 1172, 1201, 1202, 1204, 1224, 1226, 1277, 1280, 1282, 1545, 1546, 1643, 1657, 1786, 1787, 1860, 1861, 2021, 2024, 2034 and 51 more |
Product
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
Reason for recall
Maquet Critical Care AB received complaints where the FiCO2 value was not zero or as close to zero as expected and/or experienced System Check Out failures when docking the absorber to the Flow i Anesthesia machine.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1181-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.