Class I — Maquet Critical Care AB
| Recalling firm | Maquet Critical Care AB |
|---|---|
| Registered facility | MAQUET CRITICAL CARE AB (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | 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. |
| Product | Servo-u MR Ventilator System. Model Number: 6888800. |
| Quantity | 129 units |
| Distribution | US Nationwide distribution and Puerto Rico. No international distribution. |
| Initiated | 2025-05-30 |
| Classified | 2025-06-27 |
| Recall number | Z-2015-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Maquet Critical Care AB (Z-2015-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97032/
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