FDA Device recall Z-0667-2025
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthe…
- FDA Device
- Class I
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class I recall of Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthe… 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-0667-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-10-15 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Draeger Medical |
| Distribution | n/a |
Product
Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
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: 8211300; UDI-DI Number: 04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co.…Model/Catalog Number: 8211300; UDI-DI Number: 04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co., KGaA to OUS: ASTA-0314; 0315; 0325; 0338; 0340; 0384; 0411; 0425 ASTB-0002; 0010; 0018; 0151; 0160; 0161; 0165; 0175; 0176; 0177; 0178; 0179; 0180; 0181; 0182; 0214; 0215; 0218; 0232; 0233; 0234; 0235; 0236; 0248; 0249; 0250; 0262; 0263; 0264; 0265; 0266; 0276; 0277; 0278; 0279; 0280 ASTC-0008; 0025; 0036; 0037; 0038; 0039; 0040; 0041; 0042; 0046; 0047; 0048; 0049; 0050; 0062; 0063; 0064; 0077; 0078; 0079; 0080; 0081; 0089; 0090; 0091; 0092; 0093; 0102; 0103; 0104; 0123; 0124; 0125; 0126; 0127; 0133; 0139; 0140; 0150; 0151; 0152; 0153; 0154; 0169; 0176; 0177; 0178; 0179; 0182; 0183; 0184; 0185; 0186; 0187; 0192; 0195; 0196; 0200; 0201; 0202; 0203; 0242 ASTD-0028; 0051; 0052; 0080; 0081; 0082; 0083; 0084; 0085; 0086; 0087 ASTE-0012; 0013; 0014; 0015; 0041; 0042; 0043; 0044; 0063; 0064; 0065; 0084; 0176; 0177; 0178; 0179; 0243; 0244; 0282; 0299 ASTF-0005; 0006; 0019; |
|---|
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-0667-2025%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.