CLASS I ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
Atlan A350XL recalled by Draeger
Draeger is recalling Atlan A350XL, distributed in 25 states. The recall was initiated on 9 Sep 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2617-2025
- FDA event ID
- 97525
- Recalling firm
- Draeger, Telford, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 9 Sep 2025
- FDA classified
- 1 Oct 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 9 Sep 2025 | Recall initiated by company | |
| 1 Oct 2025 | Classified by FDA | +22 days |
| 8 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam.
AlabamaArizonaCaliforniaConnecticutFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyMassachusettsMinnesotaMissouriNorth CarolinaNebraskaNew MexicoNevadaNew YorkOhio
Questions about this recall
Is Atlan A350XL recalled?
Yes. Draeger recalled Atlan A350XL on 9 Sep 2025. The recall is Class I and its status is Ongoing. Recall number Z-2617-2025.
Why was it recalled?
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Which lots are affected?
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, ASUC-0174,ASUC-0175,ASUC-0176,ASUC-0178,ASUC-0179,ASUC-0180,ASUC-0181,ASUC-0182, ASUC-0183,ASUC-0184,ASUC-0185,ASUC-0186,ASUC-0187,ASUC-0188,,ASUC-0189,ASUC-0190, ASUC-0191,ASUC-0192,ASUC-0193,ASUC-0194,ASUC-0196,ASUC-0197,ASUC-0198,ASUC-0199, ASUC-0200,ASUC-0201,ASUC-0202,ASUC-0211,ASUC-0212,ASUC-0213,ASUC-0214,ASUC-0215, ASUC-0216,ASUC-0217,ASUC-0238,ASUC-0239,ASUC-0285,ASUC-0368,ASUC-0369,ASUC-0370, ASUC-0371,ASUC-0372,ASUC-0373 ASUD-0142,ASUD-0142,ASUD-0143,ASUD-0143,ASUD-0144,ASUD-0145,ASUD-0146,ASUD-0147, ASUD-0164,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0187,ASUD-0188,ASUD-0189, ASUD-0190,ASUD-0191,ASUD-0192,ASUD-0193,ASUD-0207,ASUD-0208,ASUD-0209,ASUD-0210, ASUD-0211,ASUD-0212,ASUD-0212,ASUD-0275,ASUD-0276,ASUD-0277,ASUD-0294 Serial Numbers Distributed OUS (Direct shipped from Draegerwerk AG & Co., KGaA): ASUB-0094,ASUB-0279,ASUB-0280,ASUB-0281,ASUB-0282,ASUB-0284,ASUB-0285,ASUB-0286, ASUC-0005,ASUC-0006,ASUC-0007,ASUC-0008,ASUC-0010,ASUC-0011,ASUC-0012,ASUC-0013, ASUC-0014,ASU-0042,ASUC-0043,ASUC-0044,ASUC-0045,ASUC-0046,ASUC-0047,ASUC-0048, ASUC-0049,ASUC-0050,ASUC-0051,ASUC-0052,ASUC-0053,ASUC-0054,ASUC-0057,ASUC-0060, ASUC-0073,ASUC-0074,ASUC-0075,ASUC-0076,ASUC-0077,ASUC-0078,ASUC-0079,ASUC-0080, SUC-0081,ASUC-0082,ASUC-0331,ASUC-0377,ASUC-0378,ASUC-0379,ASUD-0067,ASUD-0068, ASUD-0088,ASUD-0089,ASUD-0091,ASUD-0092,ASUD-0093,ASUD-0094,ASUD-0095,ASUD-0096, ASUD-0097,ASUD-0112,ASUD-0113,ASUD-0114,ASUD-0115,ASUD-0116,ASUD-0117,ASUD-0118, ASUD-0119,ASUD-0120,ASUD-0121,ASUD-0122,ASUD-0160,ASUD-0166
Where was it sold?
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, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Draeger
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Atlan A350 recalled by Draeger | Draeger | Device Malfunction | Nationwide |
| Device | CLASS I | Atlan A350XL recalled by Draeger | Draeger | Device Malfunction | Nationwide |
| Device | CLASS I | Vapor 3000. Unheated, calibrated anesthetic vaporizer recalled | Draeger | Potency & Assay | Nationwide |
| Device | CLASS I | Vapor 2000. Unheated, calibrated anesthetic vaporizer recalled | Draeger | Potency & Assay | Nationwide |
| Device | CLASS I | ErgoStar CM recalled by Draeger | Draeger | Device Malfunction | 10 states |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |