FDA Device recall Z-0304-2025
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
- FDA Device
- Class I
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class I recall of Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable by Draeger Medical, citing the Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0304-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-10-15 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Draeger Medical |
| Distribution | US |
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Reason
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Identifiers
| code_info | Model/Catalog Number: 8211500; UDI-DI Number: 04048675556176; Serial Numbers Distributed in the US: ASTB-0038; 0039; 01…Model/Catalog Number: 8211500; UDI-DI Number: 04048675556176; Serial Numbers Distributed in the US: ASTB-0038; 0039; 0146; 0147; 0148; 0281; 0282; 0283; 0300; 0301; 0302; 0303; 0312; 0313; 0314; 0315; 0316 ASTC-0005; 0094; 0095; 0190; 0191 ASTD-0029; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0038; 0039; 0040; 0041; 0042; 0043; 0044; 0045; 0046 0057; 0136; 0137; 0138; 0139; 0140; 0141; 0142; 0143; 0148; 0149; 0150; 0151; 0152; 0153; 0155; 0156; 0157; 0158; 0170; 0171; 0186; 0235; 0236; 0237; 0257; 0258; 0259 ASTE-0002; 0003; 0004; 0005; 0006; 0007; 0008; 0029; 0030; 0031; 0032; 0080; 0134; 0135; 0136; 0152; 0153; 0154; 0155; 0180; 0181; 0209; 0210; 0211; 0212; 0213; 0214; 0215; 0216; 0217; 0218; 0254; 0255; 0318; 0319; 0320; 0321; 0322 ASTF-0007; 0008; 0009; 0010; 0145; 0146; 0147; 0148; 0149; 0150; 0177; 0178; 0379; 0380 ASTH-0083; 0084; 0107; 0160; 0161; 0184; 0185; 0207; 0208; 0233; 0241; 0242; 0254; 0370; 0392; 0432; 0464 Serial Numbers Distributed OUS ASTA-0279; 0293; 0302; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0304-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.