FDA Device recall Z-0305-2025
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 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 A350XL Model/Catalog Number: 8621600 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-0305-2025 |
| 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 A350XL Model/Catalog Number: 8621600 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: 8621600; UDI-DI Number: 04048675556183; Serial Numbers Distributed in the US: ASTA-0307; 0309; 03…Model/Catalog Number: 8621600; UDI-DI Number: 04048675556183; Serial Numbers Distributed in the US: ASTA-0307; 0309; 0311; 0349; 0350; 0351; 0353; 0363; 0365; 0394; 0408; 0409 ASTB-0048; 0286; 0287; 0288; 0289; 0290; 0291; 0304; 0305; 0306; 0307; 0308; 0309; 0317; 0318; 0319; 0320; 0321; 0322 ASTC-0006; 0007; 0068; 0069; 0070; 0082; 0083; 0099; 0100; 0101; 0105; 0106; 0107; 0108; 0109; 0118; 0119; 0136; 0137; 0229; 0230; 0243; 0244; 0245 ASTD-0008; 0009; 0010; 0011; 0012; 0013; 0014; 0129; 0130; 0131; 0132; 0133; 0134; 0135; 0154; 0159; 0160; 0161; 0162; 0163; 0164; 0165; 0166; 0167; 0168; 0169; 0181; 0182; 0183; 0193; 0194; 0195; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245 ASTE-0016; 0017; 0077; 0078; 0079; 0086; 0087; 0122; 0123; 0124; 0125; 0126; 0129; 0130; 0131; 0163; 0164; 0165; 0166; 0171; 0172; 0173; 0174; 0195; 0196; 0197; 0198; 0203; 0225; 0226; 0246; 0247; 0248; 0249; 0250; 0278; 0279; 0280; 0281; 0301; 0302; 0303; 0304; 0305; 030 |
|---|
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-0305-2025%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.