Atlan A350XL — Class I medical device recall Z-2208-2026
Ongoing recall by Draeger, Inc., reported 2026-06-10, distributed in AR, AZ, CO, FL, MA, MN, ND, NY…. The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a
| Recall number | Z-2208-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger, Inc., Telford, PA, United States |
| Recall initiated | 2026-05-07 |
| Classified | 2026-06-04 |
| Reported by FDA | 2026-06-10 |
| Distributed | AR, AZ, CO, FL, MA, MN, ND, NY, PA, SD, WI |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CN, CO, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LT, LU, LV, MA, MX, MY, NL, NO, NP, PA, PE, PH, PK, PL, PT, QA, RO, RS, SA, SE, SI, SK, TH, TR, TW, UA, UY, VE, VN, ZA |
| Quantity | 394 units |
| UPC / GTIN / UDI-DI | 04048675556183 |
| Serial numbers | ASSH-0239, ASSH-0240, ASSH-0241, ASSH-0242, ASSH-0243, ASSH-0244, ASSH-0245, ASSH-0246, ASSH-0247, ASSH-0248, ASSH-0249, ASSH-0250, ASSH-0251, ASSH-0252, ASSH-0253, ASSH-0254, ASSL-0354, ASSL-0355, ASSL-0356, ASSL-0357, ASSL-0358, ASSL-0359, ASSL-0360, ASSL-0361, ASSM-0464 and 26 more |
| Model numbers | 8621600 |
Product
Atlan A350XL. Model Number: 8621600. anesthesia workstation
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-2208-2026. 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.