Draeger, Inc. medical device recall: Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number:…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97525
- Recall initiated
- Sep 9, 2025
- Classified by FDA
- Oct 1, 2025
- Posted in Enforcement Report
- Oct 8, 2025
- Recalling firm
- Draeger, Inc.
- Firm location
- Telford, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 9, 2025. FDA classified it 22 days later, on Oct 1, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: 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. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Belgium, Brazil, Chili, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece,… Draeger, Inc. has 7 recalls in our records.
Recalled products (2)
Z-2616-2025 Class I Ongoing
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 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
Codes / lots: Lot Code: UDI-DI Number: 04048675556176 Serial Numbers Distributed in the US: ASTB-0181 ASTC-0005,ASTC-0006,ASTC-0007 ASTD-0244,ASTD-0259 ASTE-0180,ASTE-0254,ASTE-0255 ASTH-0083,ASTH-0464 ASUA-0479,ASUA-0482 ASUB-0012,ASUB-0013,ASUB-0015,ASUB-0017,ASUB-0018,ASUB-0292 ASUC-0065,ASUC-0084,ASUC-0085,ASUC-0086,ASUC-0087,ASUC-0088,ASUC-0090,ASUC-0091, ASUC-0092,ASUC-0096,ASUC-0097,ASUC-0099,ASUC-0100,ASUC-0101,ASUC-0102,ASUC-0103, ASUC-0104,ASUC-0105,ASUC-0107,ASUC-0108,ASUC-0109,ASUC-0110,ASUC-0111,ASUC-0112, ASUC-0113,ASUC-0116,ASUC-0117,ASUC-0118,ASUC-0119,ASUC-0120,ASUC-0121,ASUC-0122, ASUC-0123,ASUC-0125,ASUC-0126,ASUC-0127,ASUC-0128,ASUC-0129,ASUC-0130,ASUC-0131, ASUC-0132,ASUC-0133,ASUC-0134,ASUC-0135,ASUC-0136,ASUC-0137,ASUC-0138,ASUC-0139, ASUC-0140,ASUC-0141,ASUC-0142,ASUC-0143,ASUC-0143,ASUC-0144,ASUC-0145,ASUC-0162,…
Quantity: 530
Z-2617-2025 Class I Ongoing
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
Codes / lots: Lot Code: UDI-DI Number: 04048675556183 Serial Numbers Distributed in the US: ASTA-0307,ASTA-0309,ASTA-0311,ASTA-0349,ASTA-0350,ASTA-0409 ASTB-0048 ASTC-0244,ASTC-0245 ASTD-0008,ASTD-0009,ASTD-0010,ASTD-0011,ASTD-0013,ASTD-0014,ASTD-0212,ASTD-0239 ASTH-0307,ASTH-0308,ASTH-0309,ASTH-0310,ASTH-0311,ASTH-0332,ASTH-0333,ASTH-0334, ASTH-0335,ASTH-0336,ASTH-0383,ASTH-0384 ASTJ-0014 ASUA-0469,ASUA-0483,ASUA-0484,ASUA-0486,ASUA-0488 ASUB-0093,ASUB-0169,ASUB-0170,ASUB-0171,ASUB-0172,ASUB-0173,ASUB-0174,ASUB-0175, ASUB-0176,ASUB-0183,ASUB-0184,ASUB-0185,ASUB-0186,ASUB-0187,ASUB-0215,ASUB-0216, ASUB-0217,ASUB-0218,ASUB-0219,ASUB-0221,ASUB-0222,ASUB-0250,ASUB-0251,ASUB-0266, ASUB-0267, ASUB-0268,ASUB-0269,ASUB-0270 ASUC-0067,ASUC-0068,ASUC-0069,ASUC-0072,ASUC-0114,ASUC-0115,ASUC-0146,ASUC-0148, ASUC-0149,ASUC-0150,ASUC-0151,ASUC-0153,ASUC-0155,ASUC-0156,ASUC-0157,ASUC-0158,…
Quantity: 223
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97525
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.