Recall archive / FDA device enforcement
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product D... — FDA record Z-2617-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 9, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
- Classification
- Class I
- Recalling firm
- Draeger, Inc.
- Quantity
- 223
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2617-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 8, 2025
- Recall initiation date
- Sep 9, 2025
- Center classification date
- Oct 1, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.