FDA Device recall Z-2160-2025
HME TwinStar HEPA Plus Filter
- FDA Device
- Class I
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class I recall of HME TwinStar HEPA Plus Filter by Draeger, citing reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2160-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-06-16 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Draeger |
| Distribution | US |
Product
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Reason
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Identifiers
| code_info | Model No. MP05801; UDI: 04048675665823; All Lots. |
|---|
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-2160-2025%22
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