HME TwinStar HEPA Plus Filter — Class I medical device recall Z-2160-2025
Ongoing recall by Draeger, Inc., reported 2025-08-06, distributed nationwide. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
| Recall number | Z-2160-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger, Inc., Telford, PA, United States |
| Recall initiated | 2025-06-16 |
| Classified | 2025-07-31 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, ES, FR, GB, GR, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LV, MA, MX, MY, NG, NL, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SG, SI, SK, SV, TH, TR, TT, TW, UA, VN, ZA |
| Quantity | 1,019,782 units |
| UPC / GTIN / UDI-DI | 04048675665823 |
| Model numbers | MP05801 |
Product
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Reason for recall
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
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-2160-2025. 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.