Brand Name: Atlan Product Name: Atlan A350
Medical device recall Z-2616-2025. Published in FDA’s Enforcement Report on Oct 8, 2025.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 8, 2025. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- 25 states named in where it went
- 530 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
530, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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,…
FDA’s list runs to 5,378 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
25 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Connecticut
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Mexico
- Nevada
- New York
- Ohio
- Pennsylvania
- Texas
- Utah
- Virginia
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 9, 2025.
- FDA classified it on Oct 1, 2025.
- FDA’s Enforcement Report published it on Oct 8, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Draeger, Inc., of Telford, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,378 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.