Servo-n Ventilator System — Class I medical device recall Z-2014-2025
Ongoing recall by Maquet Critical Care AB, reported 2025-07-09, distributed nationwide. Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to
| Recall number | Z-2014-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Critical Care AB, Solna, Sweden |
| Recall initiated | 2025-05-30 |
| Classified | 2025-06-27 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 7,688 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07325710001110 |
| Model numbers | 6694800 |
Product
Servo-n Ventilator System. Model Number: 6694800.
Reason for recall
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
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-2014-2025. 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.