BiPAP V30 Auto Ventilator
Medical device recall Z-1812-2024. 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
- 5,958 US; None 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 V30 Auto Ventilator, Part Number 1111178
5,958 US; None OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI 00606959049635 Serial Numbers N2068642229E4 N206864244CD2 N206864255D5B N206864277E49 N2068642886BE N206864299737 N2068643102A7 N20686432303C N2068643321B5 N20686434550A N206864354483 N206864367618 N206864376791 N206864389F66…
Every code shown here, 1,997 characters
UDI-DI 00606959049635 Serial Numbers N2068642229E4 N206864244CD2 N206864255D5B N206864277E49 N2068642886BE N206864299737 N2068643102A7 N20686432303C N2068643321B5 N20686434550A N206864354483 N206864367618 N206864376791 N206864389F66 N206864398EEF N206864405E26 N206864414FAF N206864427D34 N206864441802 N20686445098B N206864463B10 N206864472A99 N20686448D26E N20686449C3E7 N2068645047FE N206864515677 N2068645264EC N206864537565 N2068645401DA N206864551053 N2068645622C8 N206864573341 N20686458CBB6 N206864606D96 N206864617C1F N206864624E84 N206864635F0D N206864653A3B N2068646608A0 N2070799636A7 N20708029041F N20708103C229 N20708105A71F N2070811974AB N20708120C302 N20708137AE65 N20708141865B N20708147E36D N20713207A038 N20713212EE4D N207132184117 N20713222C425 N20713232DDFD N2071323872A7 N20713245E44A N207132582677 N20713270998F N207132810BCE N2071329445BB N2071329666A9 N207132977720 N207132988FD7 N207132999E5E N20713309139A N20713314D1A7 N207133190A42 N20713327C954 N207133328721 N2071333396A8 N2071335695D5 N20713363E810 N2071337594FE N20713377B7EC N2071338625AD N207133972DFC N207134088E16 N207134099F9F N207134145DA2 N207134212067 N2071342654D8 N207134375C89 N20713442462C N2071344357A5 N207134507CE6 N207134726C44 N2071347518FB N207134762A60 N20713478C31E N207134859B33 N205345571B7A N20534558E38D N20534559F204 N2053456045AD N2053456266BF N205345637736 N205345640389 N205345651200 N20534566209B N205345673112 N20534568C9E5 N20534569D86C N205345705C75 N205345714DFC N205345727F67 N205345736EEE N205345741A51 N205345750BD8 N206864266FC0 N20686430132E N206864436CBD N206864671929 N20686470744E N2068647165C7 N20686472575C N2068647346D5 N20686474326A N206864761178 N2068647700F1 N20686478F806 N20686479E98F N20686482D494 N20686483C51D N20686484B1A2 N20686485A02B N2068648692B0 N206864878339 N206864887BCE N20713231EF66 N207132955432 N207133019FD2 N207134740972 N207134773BE9 N20713479D297 N205345615424 N20686469F057 N20686480F786 N207082010E5F N20713263B2CC N206864642BB2 N20686468E1DE…
FDA’s list runs to 83,450 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 83,450 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
-
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.