Agency classClass IOur severity:Severe FDA (Devices)·Z-2035-2025·Announced 2025-07-09

BiPAP V30 Auto ventilators are not indicated for respiratory failure

The Philips Respironics BiPAP V30 Auto Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 5,958 units affected.

The agency’s classification

FDA (Devices): Class I

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death or injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

The BiPAP V30 Auto Ventilator from Philips Respironics, Inc., intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg, part number 1111178, UDI 0060959049635, is being recalled. The action covers 5,958 units, identified by the serial numbers in the recall notice.

The stated reason is that this device does not indicate for use in patients with respiratory failure. The FDA classified the action as Class I, its most serious classification.

Distribution was worldwide, including nationwide in the United States with Guam and Puerto Rico, and to the United Arab Emirates, Argentina, Austria, Australia, Bosnia and Herzegovina, Belgium and other markets.

Facilities should identify affected units using the part number, UDI and serial numbers in the recall notice and follow the instructions issued by Philips Respironics.

The recalled product

Product: BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Manufacturer: Philips Respironics, Inc.
Category: Medical Device — Ventilator
Hazard: indication-limitation
respiratory-failure
ventilator
class-i
Affected units: 5,958

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Part Number 1111178
UDI: 0060959049635
Serial No. N2068642229E4
N206864244CD2
N206864255D5B
N206864277E49
N2068642886BE
N206864299737
N2068643102A7
N20686432303C
N2068643321B5
N20686434550A
N206864354483
N206864367618
N206864376791
N206864389F66
N206864398EEF
N206864405E26
N206864414FAF
N206864427D34

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Philips Respironics, Inc.

See all →

Severe
Trilogy EV300 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
Severe
Trilogy Evo O2 obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
Severe
Trilogy Evo obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
Severe
Trilogy Evo Universal obstruction alarm may take up to four breaths
FDA (Devices) · 2026-04-08
Severe
Trilogy EV300 ventilator recalled as Class I over tidal volume
FDA (Devices) · 2026-04-01

Same hazard · indication limitation