Drager SafeStar 55 — Class I medical device recall Z-1211-2022
Ongoing recall by Draeger Medical, Inc., reported 2022-06-22, distributed nationwide. Possible occlusion of filters due to manufacturing error.
| Recall number | Z-1211-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2022-05-16 |
| Classified | 2022-06-10 |
| Reported by FDA | 2022-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, CA, CH, CZ, DE, DK, ES, FR, GB, HR, ID, IE, IN, IT, JP, KR, LV, MA, MY, NL, NO, PH, PT, RO, RS, SA, SE, SK, TH, ZA |
| Quantity | 35,950 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04048675026785 |
| Lot numbers | LT2103 |
| Model numbers | MP01790 |
Product
Drager SafeStar 55, Catalog No. MP01790
Reason for recall
Possible occlusion of filters due to manufacturing error.
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-1211-2022. 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.