Trilogy Evo O2 EV300
Medical device recall Z-1651-2023. Published in FDA’s Enforcement Report on Jun 14, 2023.
- 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 Jun 14, 2023. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 18,855 devices 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?
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
18,855 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 606959052017 606959056497 606959061033 606959052321 606959058613 606959058620 606959058644 606959058668 606959058675 606959058682 606959058705 606959058798; Serial Numbers: H800088856BDC H800088865947 H80008889A1B0 H800088913420…
Every code shown here, 1,987 characters
UDI-DI: 606959052017 606959056497 606959061033 606959052321 606959058613 606959058620 606959058644 606959058668 606959058675 606959058682 606959058705 606959058798; Serial Numbers: H800088856BDC H800088865947 H80008889A1B0 H800088913420 H8000889206BB H800089218A54 H295004989AF7 H295005081733 H29500526CDFD H29500537C5AC H29500543CE80 H29500550E5C3 H29500557917C H29500562ECB9 H2950058276A9 H29500589C87A H295005940A47 H2950064102F6 H29500644555B H2950064767C0 H295006500AA7 H295006566F91 H295006577E18 H295006599766 H29500695F4AA H295007020DD1 H29500710371B H29500716522D H295007210CFA H2950072769CC H295007333630 H29500748C5EB H29500782C311 H29500785B7AE H29500791E852 H29500808E84C H295008107DDC H2950081618EA H295008304E6C H295008362B5A H295008400364 H2950084554C9 H2950086030D4 H2950086213C6 H29500867446B H295008731B97 H29500878A544 H29500881BB4D H29500883985F H29500885FD69 H295109734A0F H295684188A77 H29568454277B H295684894CE6 H2956852613BD H295702706AAA H295702771E15 H29570309E0BF H2957035666F0 H295722010F5D H29571147C7A2 H295733206B03 H29638720E91A H2957187552C6 H29570525CFBA H295714846524 H29571655716D H29572553DEF2 H295726025EA7 H2957263057DD H295721975217 H29572909AAB3 H29572948DC5A H295731629AC9 H29573293E7EC H29572435B5C8 H295733352576 H295749410A01 H295753542BB5 H29575430B544 H295754469D7A H29575462E8EE H29575472F136 H29575718E5D8 H295759024341 H295759576A54 H29576146810A H295772160C6D H29577227378C H29577239C72A H295772522D29 H29577269B992 H295772774934 H2957735631D1 H2957737176DE H29577382C78D H29638222F3B5 H296384752F6B H296385152167 H29638556749C H296385674F7D H29638579BFDB H29638661C52F H296386649282 H296386694967 H29638673FFE5 H296386804EB6 H29638692747C H29638700DAAA H29638711D2FB H295727388149 H29638731E14B H296387429ED8 H29638754E236 H296387619FF3 H296387790A63 H29638786715C H29638860C4BD H29638870DD65 H29638877A9DA H2963889375EE H29638924BF25 H29638946C8E7 H2963896903A0 H2963898770CE H296389901DA9 H296412616FF1 H296412634CE3 H2964127067A0…
FDA’s list runs to 264,158 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.
US Nationwide. Global Distribution.
These words name no state.
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?
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 May 1, 2023.
- FDA classified it on Jun 2, 2023.
- FDA’s Enforcement Report published it on Jun 14, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips Respironics, Inc., of Murrysville, 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 264,158 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.