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Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not...

FDA Device Recall #Z-2616-2025 — Class I — September 9, 2025

Recall Summary

Recall Number Z-2616-2025
Classification Class I — Serious risk
Date Initiated September 9, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Draeger, Inc.
Location Telford, PA
Product Type Devices
Quantity 530

Product Description

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

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.

Distribution Pattern

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.

Lot / Code Information

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, ASUC-0163,ASUC-0164,ASUC-0165,ASUC-0166,ASUC-0167,ASUC-0168,ASUC-0169,ASUC-0170, ASUC-0171,ASUC-0172,ASUC-0173,ASUC-0203,ASUC-0204,ASUC-0205,ASUC-0206,ASUC-0207, ASUC-0208,ASUC-0209,ASUC-0210,ASUC-0218,ASUC-0219,ASUC-0220,ASUC-0221,ASUC-0222, ASUC-0223,ASUC-0224,ASUC-0225,ASUC-0235,ASUC-0236,ASUC-0237,ASUC-0340,ASUC-0341 ASUD-0244,ASUD-0261,ASUD-0262,ASUD-0263,ASUD-0267,ASUD-0281,ASUD-0282,ASUD-0283 Serial Numbers Distributed OUS ASUA-0353,ASUA-0441,ASUA-0447,ASUA-0472,ASUA-0478,ASUA-0496,,SUA-0497,ASUA-0500, ASUB-0004,ASUB-0024,ASUB-0025,ASUB-0030,ASUB-0033,ASUB-0034,ASUB-0035,ASUB-0038, ASUB-0039,ASUB-0040,ASUB-0041,ASUB-0043,ASUB-0044,ASUB-0046,ASUB-0048,ASUB-0063, ASUB-0064,ASUB-0066,ASUB-0067,ASUB-0069,ASUB-0073,ASUB-0074,ASUB-0075,ASUB-0076, ASUB-0077,ASUB-0095,ASUB-0096,ASUB-0097,ASUB-0098,ASUB-0099,ASUB-0100,ASUB-0101, ASUB-0102,ASUB-0104,ASUB-0105,ASUB-0107,ASUB-0108,ASUB-0109,ASUB-0112,ASUB-0113, ASUB-0114,ASUB-0115,ASUB-0116,ASUB-0118,ASUB-0120,ASUB-0121,ASUB-0122,ASUB-0123, ASUB-0124,ASUB-0128,ASUB-0129,ASUB-0130,ASUB-0136,ASUB-0137,ASUB-0139,ASUB-0140, ASUB-0141,ASUB-0143,ASUB-0144,ASUB-0145,ASUB-0146,ASUB-0147,ASUB-0148,ASUB-0149, ASUB-0150,ASUB-0151,ASUB-0152,ASUB-0153,ASUB-0154,ASUB-0155,ASUB-0156,ASUB-0157, ASUB-0158,ASUB-0159,ASUB-0160,ASUB-0161,ASUB-0162,ASUB-0163,ASUB-0177,ASUB-0178, ASUB-0188,ASUB-0189,ASUB-0190,ASUB-0191,ASUB-0192,ASUB-0193,ASUB-0194,ASUB-0195, ASUB-0196,ASUB-0197,ASUB-0198,ASUB-0199,ASUB-0201,ASUB-0202,ASUB-0203,ASUB-0204, ASUB-0205,ASUB-0206,ASUB-0207,ASUB-0208,ASUB-0209,ASUB-0210,ASUB-0211,ASUB-0223, ASUB-0224,ASUB-0225,ASUB-0226,ASUB-0227,ASUB-0229,ASUB-0230,ASUB-0231,ASUB-0232, ASUB-0233,ASUB-0234,ASUB-0235,ASUB-0236,ASUB-0237,ASUB-0238,ASUB-0240,ASUB-0243, ASUB-0245,ASUB-0252,ASUB-0253,ASUB-0254,ASUB-0255,ASUB-0256,ASUB-0257,ASUB-0258, ASUB-0260,ASUB-0261,ASUB-0262,ASUB-0263,ASUB-0264,ASUB-0265,ASUB-0271,ASUB-0272, ASUB-0273,ASUB-0276,ASUB-0278,ASUC-0001ASUC-0004,ASUC-0016,ASUC-0017,ASUC-0018, ASUC-0019,ASUC-0020,ASUC-0022,ASUC-0024,ASUC-0026,,ASUC-0028,,ASUC-0030,ASUC-0031, ASUC-0032,ASUC-0033,ASUC-0034,ASUC-0035,ASUC-0036,ASUC-0039,ASUC-0061,ASUC-0062, ASUC-0063,ASUC-0226,ASUC-0227,ASUC-0228,ASUC-0229,ASUC-0230,ASUC-0232,ASUC-0233, ASUC-0234,ASUC-0247,ASUC-0248,ASUC-0249,ASUC-0250,ASUC-0251,ASUC-0252,ASUC-0253, ASUC-0254,ASUC-0255,ASUC-0256,ASUC-0257,ASUC-0262,ASUC-0263,ASUC-0264,ASUC-0265, ASUC-0266,ASUC-0267,ASUC-0269,ASUC-0272,ASUC-0273,ASUC-0274,ASUC-0275,ASUC-0276, ASUC-0277,ASUC-0278,ASUC-0279,ASUC-0284,ASUC-0286,ASUC-0287,ASUC-0288,ASUC-0289, ASUC-0290,ASUC-0291,ASUC-0292,ASUC-0293,ASUC-0294,ASUC-0295,ASUC-0296,ASUC-0300, ASUC-0301,ASUC-0302,ASUC-0303,ASUC-0304,ASUC-0305,ASUC-0306ASUC-0307,ASUC-0308, ASUC-0309,ASUC-0310,ASUC-0311,ASUC-0314,ASUC-0315,ASUC-0316,ASUC-0319,ASUC-0320, ASUC-0321,ASUC-0322,ASUC-0323,ASUC-0339,ASUC-0342,ASUC-0343,ASUC-0344,ASUC-0345, ASUC-0346,ASUC-0348,ASUC-0349,ASUC-0350,ASUC-0351,ASUC-0352,ASUC-0353,ASUC-0354, ASUC-0355,ASUC-0356,ASUC-0357,ASUC-0358,ASUC-0359,ASUC-0360,ASUC-0361,ASUC-0362, ASUC-0363,ASUC-0364,ASUC-0365,ASUC-0366,ASUC-0367,ASUC-0380,ASUC-0381,ASUC-0382, ASUC-0383,ASUC-0384,ASUC-0385,ASUC-0386,ASUC-0387,ASUC-0391,ASUC-0392,ASUC-0393, ASUC-0394,ASUC-0395,ASUC-0396,ASUC-0397,ASUC-0398,ASUC-0399,ASUC-0400,ASUC-0401, ASUC-0402,ASUC-0403,ASUC-0404,ASUC-0405,ASUC-0406,ASUC-0407,ASUC-0408,ASUC-0409, ASUC-0410,ASUC-0416,ASUD-0001,ASUD-0002,ASUD-0004,ASUD-0005,ASUD-0006,ASUD-0007, ASUD-0008,ASUD-0009,ASUD-0010,ASUD-0011,ASUD-0012,ASUD-0013,ASUD-0014,ASUD-0015, ASUD-0016,ASUD-0018,ASUD-0019,ASUD-0020,ASUD-0022,ASUD-0023,ASUD-0041,ASUD-0042, ASUD-0043,ASUD-0044,ASUD-0046,ASUD-0047,ASUD-0048,ASUD-0049,ASUD-0050,ASUD-0051, ASUD-0057,ASUD-0059,ASUD-0060,ASUD-0061,ASUD-0062,ASUD-0063,ASUD-0064,ASUD-0065, ASUD-0066,ASUD-0074,ASUD-0075,ASUD-0077,ASUD-0078,ASUD-0079,ASUD-0080,ASUD-0081, ASUD-0098,ASUD-0099,ASUD-0100,ASUD-0101,ASUD-0102,ASUD-0103,ASUD-0104,ASUD-0105, ASUD-0106,ASUD-0107,ASUD-0108,ASUD-0109,ASUD-0126,ASUD-0127,ASUD-0128,ASUD-0129, ASUD-0130,ASUD-0131,ASUD-0133,ASUD-0135,ASUD-0136,ASUD-0140,ASUD-0141,ASUD-0150, ASUD-0168,ASUD-0173,ASUD-0174,ASUD-0175,ASUD-0181,ASUD-0182,ASUD-0183,ASUD-0184, ASUD-0185,ASUD-0186,ASUD-0196,ASUD-0198,ASUD-0199,ASUD-0200,ASUD-0201,ASUD-0202, ASUD-0203,ASUD-0204,ASUD-0205,ASUD-0206,ASUD-0219,ASUD-0220,ASUD-0221,ASUD-0222, ASUD-0223,ASUD-0224,ASUD-0225,ASUD-0226,ASUD-0227,ASUD-0228,ASUD-0238,ASUD-0239, ASUD-0245,ASUD-0246,ASUD-0247,ASUD-0248,ASUD-0249,ASUD-0250,ASUD-0251,ASUD-0252, ASUD-0253,ASUD-0258,ASUD-0259,ASUD-0260,ASUD-0273,ASUD-0274

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Z-0593-2026 Class I ErgoStar CM 60, Model/Catalog Number: MP01860... Nov 10, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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