OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141…
Medical device recall Z-1817-2024. Published in FDA’s Enforcement Report on May 29, 2024.
- 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 May 29, 2024. 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
- 9,388 US; 2,664 ROW 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?
Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
9,388 US; 2,664 ROW, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number / UDI-DI/ Serial Numbers: 1111122 / UDI-DI 606959067813 Serial Numbers L097964930206 L09796498BCD5 L09796510A481 L097965381B79 L0979657784EE L097965971EFE L09796767288E L09796779D828 L097968136965 L097968141DDA L097968163EC8…
Every code shown here, 1,995 characters
Product Number / UDI-DI/ Serial Numbers: 1111122 / UDI-DI 606959067813 Serial Numbers L097964930206 L09796498BCD5 L09796510A481 L097965381B79 L0979657784EE L097965971EFE L09796767288E L09796779D828 L097968136965 L097968141DDA L097968163EC8 L09796818D7B6 L09796819C63F L097968225284 L09796823430D L0979682437B2 L09796825263B L097968270529 L09796829EC57 L0979684751F9 L09796849B887 L097968512D17 L097968521F8C L0981390546A9 L098140911CAA L098141339814 L100102519380 L10010275E614 L1001028123F8 L1001028565DC L1001028746CE L10010288BE39 L100102913A20 L100102975F16 L1001030394F6 L10010310BFB5 L100103138D2E L10010338004D L1001034596A0 L100103558F78 L1001039705CA L100104165686 L10010417470F L100104223ACA L100104300000 L103082023D42 L103905201559 L10638229B96A L1063826260D9 L106382750DBE L10638290C003 L106383073978 L106383114596 L1087900826E2 L10879015E4DF L11022823358F L1102293730AF L110456413EEF L110706047DB9 L110708377551 L11070894BABA L11070899615F L11070900715A L11070906146C L110709489A72 L110709500FE2 L11081466C984 L110815129874 L110815290CCF L110815669358 L110817023414 L11136407983B L112492807AC5 L11249288F68D L11249292400F L112492935186 L112492942539 L11249296062B L1124929717A2 L11249299FEDC L11249304A8FD L112493086291 L11249312D413 L122858118744 L12735071463D L12945235DBBF L1323076570C1 L13230766425A L1323076753D3 L13230768AB24 L13230769BAAD L1330033132DB L13300393ECB9 L186537949AFB L18653797A860 L21271600A5A0 L22035135ABA4 L22035136993F L220351387041 L2203513961C8 L22226897CF07 L2222689837F0 L22977035C06D L229770390A01 L22977042F9DA L22977043E853 L229770449CEC L229770458D65 L22977046BFFE L22977047AE77 L229770485680 L229770494709 L22977050C310 L22977051D299 ; 1111123 / UDI-DI 606959067820 Serial Numbers L111838125A56 L11249556238E L113839345E5A L114895520A60 L11489624CD3A L122772495544 L12277265AC98 L122820001EF6 L122820010F7F L122820023DE4 L12600251B785 L12600256C33A L14644753AA1B L14644754DEA4 L150166760CD7 L150166771D5E L15229405619F L16241620C614 L16241621D79D…
FDA’s list runs to 169,493 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 distribution and OUS International distribution to Canada.
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.
The words say it went outside the United States too.
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 Apr 1, 2024.
- FDA classified it on May 23, 2024.
- FDA’s Enforcement Report published it on May 29, 2024.
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 169,493 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.