Apollo Anesthesia Machine
Medical device recall Z-2253-2018. Published in FDA’s Enforcement Report on Jun 27, 2018.
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 Jun 27, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 33 states named
- 72 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification. It is an inhalation anesthesia machine for use in operating, induction, and recovery rooms. It can be used with rebreathing systems, semiclosed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems (with the Auxiliary Common Gas Outlet). It may be used with O2, N2O, and Air supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine. The Apollo is equipped with a compact breathing system, providing fresh-gas decoupling, PEEP, and pressure limitation. It has an electrically driven and electronically controlled ventilator.
72, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
ASKM-0152 ASKN-0138 ASKM-0193 ASKN-0139 ASKM-0202 ASKN-0143 ASKM-0203 ASKN-0144 ASKM-0211 ASKN-0148 ASKM-0212 ASKN-0150 ASKM-0213 ASKN-0151 ASKM-0214 ASKN-0152 ASKM-0221 ASKN-0163 ASKM-0222 ASKN-0164 ASKM-0227 ASKN-0165 ASKM-0228 ASLA-0001…
Every code shown here, 719 characters
ASKM-0152 ASKN-0138 ASKM-0193 ASKN-0139 ASKM-0202 ASKN-0143 ASKM-0203 ASKN-0144 ASKM-0211 ASKN-0148 ASKM-0212 ASKN-0150 ASKM-0213 ASKN-0151 ASKM-0214 ASKN-0152 ASKM-0221 ASKN-0163 ASKM-0222 ASKN-0164 ASKM-0227 ASKN-0165 ASKM-0228 ASLA-0001 ASKM-0246 ASLA-0002 ASKM-0269 ASLA-0003 ASKM-0272 ASLA-0092 ASKM-0328 ASLA-0121 ASKM-0332 ASLA-0124 ASKM-0333 ASLA-0131 ASKM-0337 ASLA-0132 ASKM-0339 ASLA-0145 ASKM-0340 ASLA-0146 ASKM-0360 ASLA-0152 ASKM-0362 ASLA-0153 ASKM-0366 ASLA-0154 ASKM-0370 ASLA-0163 ASKM-0371 ASLA-0164 ASKM-0408 ASLA-0165 ASKM-0409 ASLA-0166 ASKM-0415 ASLA-0173 ASKN-0012 ASLA-0174 ASKN-0035 ASLA-0175 ASKN-0039 ASLA-0179 ASKN-0040 ASLA-0180 ASKN-0113 ASLA-0181 ASKN-0114 ASLA-0182 ASKN-0116 ASLA-0183
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.
US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
The states and territories these words name
33 states and territories.
Every one of them
- Alaska
- Alabama
- Arizona
- California
- Colorado
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Massachusetts
- Maryland
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Tennessee
- Texas
- Utah
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 May 24, 2018.
- FDA classified it on Jun 19, 2018.
- FDA’s Enforcement Report published it on Jun 27, 2018.
- FDA terminated it on May 12, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Draeger Medical, 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.”
- 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
-
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.