BiPAP A30 Ventilator
Medical device recall Z-1814-2024. 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, and 2 states named
- 3 US; 21,414 OUS 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?
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
3 US; 21,414 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
US distribution: Material No. 1111143 UDI-DI 00606959039308 Serial Numbers N182942836566 N14644718E852 N16489657EE4B -- OUS distribution: Material No. 1111143 UDI-DI 606959067493 Serial Nos. N09765363D900 N09765365BC36 N097653668EAD…
Every code shown here, 1,997 characters
US distribution: Material No. 1111143 UDI-DI 00606959039308 Serial Numbers N182942836566 N14644718E852 N16489657EE4B -- OUS distribution: Material No. 1111143 UDI-DI 606959067493 Serial Nos. N09765363D900 N09765365BC36 N097653668EAD N097653679F24 N102712420C4C N102712431DC5 N1027125470A2 N10271255612B N1027125653B0 N10271258BACE N10271259AB47 N102712601CEE N102712610D67 N102712623FFC N102712632E75 N102712654B43 N1027126679D8 N1027126890A6 N102712700536 N1027127114BF N10271275529B N102712777189 N10271282A5EC N10271283B465 N10271285D153 N10271287F241 N102712880AB6 N102712891B3F N102712909F26 N10271292BC34 N10271293ADBD N10271294D902 N10271295C88B N10271297EB99 N10271298136E N1027129902E7 N1027130012E2 N10271307665D N102713089EAA N102713100B3A N102713122828 N102713155C97 N102713177F85 N1027131996FB N1027132313C9 N1027132576FF N10271329BC93 N102713356F27 N102713365DBC N102713374C35 N102713517DD3 N10271356096C N102713626520 N102713714E63 N102713727CF8 N10271390C5FA N10271410873F N1027141196B6 N10271413B5A4 N10271428211F N10271439294E N10271440F987 N10271442DA95 N10271443CB1C N102714496446 N10271473E174 N1027147495CB N102714758442 N10271476B6D9 N10271477A750 N102714794E2E N102714841603 N10271489CDE6 N102714926AED N102714951E52 N10271499D43E N10271503F6A0 N10271504821F N102715059396 N10271506A10D N10271511CC6A N10271513EF78 N1027151851AB N10271520F78B N10271521E602 N10271522D499 N10271523C510 N10271524B1AF N102715278334 N10271530EE53 N10271531FFDA N10271533DCC8 N102715368B65 N102715379AEC N102715397392 N102715428049 N1027154391C0 N10271547D7E4 N102715482F13 N10271550BA83 N10271551AB0A N102715538818 N10271554FCA7 N10271556DFB5 N10271557CE3C N1027156090EB N102715618162 N10271563A270 N10271565C746 N10271566F5DD N102715681CA3 N102715690D2A N102715708933 N1027157198BA N10271573BBA8 N10271576EC05 N102715811B72 N1027158229E9 N102715844CDF N102715855D56 N102715866FCD N102715877E44 N102715901323 N1027159102AA N1027159321B8 N102715967615 N102715998EE2 N102716002B5F N10271602084D…
FDA’s list runs to 300,901 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.
Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.
The states and territories these words name
- Guam
- Puerto Rico
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 Mar 26, 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 300,901 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.