Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number:… — Class I medical device recall Z-0305-2025
Ongoing recall by Draeger Medical, Inc., reported 2024-11-20, distributed nationwide. The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a
| Recall number | Z-0305-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger Medical, Inc., Telford, PA, United States |
| Recall initiated | 2024-10-15 |
| Classified | 2024-11-13 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CN, CZ, DE, EE, EG, ES, FI, FR, GB, GR, HR, HU, ID, IE, IN, IT, JO, JP, KE, KR, LV, MA, MX, MY, NP, PA, PE, PH, PK, PL, PT, RO, RS, SA, SE, SI, SK, SV, TH, TR, TW, UA, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 04048675556183 |
| Model numbers | 8621600 |
Product
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Reason for recall
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
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-0305-2025. 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.