Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number:… — Class I medical device recall Z-2617-2025
Ongoing recall by Draeger, Inc., reported 2025-10-08, distributed in AL, AZ, CA, CT, FL, GA, ID, IL…. The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechani
| Recall number | Z-2617-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Draeger, Inc., Telford, PA, United States |
| Recall initiated | 2025-09-09 |
| Classified | 2025-10-01 |
| Reported by FDA | 2025-10-08 |
| Distributed | AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI |
| Countries outside the US | AR, AU, BE, BR, CH, CN, DE, DK, EC, ES, FR, GB, GR, HR, HU, ID, IN, IT, JO, JP, KR, KW, LT, MX, NL, PE, PL, RO, RS, SA, SE, TR, TW, VN, ZA |
| Quantity | 223 |
| UPC / GTIN / UDI-DI | 04048675556183 |
| Model numbers | 8621600 |
Product
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable
Reason for recall
The device 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-2617-2025. 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.