Trilogy Evo, Garbin Evo, and Aeris EVO
Medical device recall Z-1649-2023. 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
- 57,395 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, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B
57,395 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 606959051942 606959051959 606959051973 606959051980 606959055452 606959052307 606959055476 606959055483 606959055490 606959062092 606959055506 606959055513 606959055421 606959054080 606959054110 606959055520 606959054127…
Every code shown here, 1,992 characters
UDI-DI: 606959051942 606959051959 606959051973 606959051980 606959055452 606959052307 606959055476 606959055483 606959055490 606959062092 606959055506 606959055513 606959055421 606959054080 606959054110 606959055520 606959054127 606959054981 606959055544 606959057432 606959062962; Serial Numbers: H316330493348 H31633062BE2B H31633067E986 H3163306900F8 H316330719568 H31633072A7F3 H31633073B67A H31633074C2C5 H31633077F05E H31633084410D H316330899AE8 H316330910F78 H316330923DE3 H3163309892B9 H31633102B027 H3168304974A4 H31683060DAD5 H31683061CB5C H31683081514C H3168308263D7 H3168308406E1 H31683087347A H31683088CC8D H31683090591D H316830927A0F H316830936B86 H316830941F39 H31683100D4D9 H31683101C550 H31683102F7CB H31696034875A H31696053A735 H31696059086F H316960638D5D H31696067CB79 H316960739485 H31696077D2A1 H3169608206C4 H3169608640E0 H316960921F1C H3169609748B1 H31696101A043 H31696105E667 H31696118245A H31696123B0E1 H317352405480 H317354480E11 H31735507CB5A H31735568677D H317359517577 H31735981C50F H317406346246 H3174065070B2 H317406543696 H317406740526 H31740679DEC3 H31740686A5FC H31740691C89B H31740696BC24 H31740701455F H317964963E72 H318068788452 H31806883B949 H31806884CDF6 H31806885DC7F H31806888079A H318368546042 H3183685571CB H318368564350 H31836858AA2E H31861740040C H3186181302E8 H318619467121 H3186198831FF H31862000CAA4 H31961173CE0D H320015337C89 H320015731BE9 H3204332184FC H32043326F043 H32107976A656 H321079795EA1 H321542678438 H321542687CCF H322097635A07 H32209769F55D H3220978697BA H32209790EB54 H322097968E62 H3220980430AF H322098117EDA H32209818E31B H322581438581 H32258144F13E H32258145E0B7 H32258146D22C H32258147C3A5 H323157817B5E H32315798FF47 H32315830C4B8 H32315965B771 H323159861FFA H323160033F44 H323160203E6F H3231604249AD H32316060590F H32316078CC9F H3231612247A1 H32316139E0AA H32316159B47A H32316167776C H32316185CE6E H323161890402 H323172129E16 H3231723802FC H32317242E0AE H3231726784B3 H32317301EF89 H32317305A9AD H32317310E7D8 H3231733583C5…
FDA’s list runs to 803,851 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 803,851 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.