FDA Medical devices recall ·
BiPAP V30 Auto Ventilator recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2035-2025
- Date
- (initiated May 9, 2025)
- Company / brand
- Philips Respironics, Inc.
1001 Murry Ridge Ln, Murrysville, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 5,958 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Why was it recalled?
This device does not indicate for use in patients with respiratory failure.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 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, N2053456
Distribution
Worldwide distribution: US (Nationwide)including Guam and Puerto Rico; OUS (Foreign) to countries of: United Arab Emirates (AE), Argentina (AR), Austria (AT), Australia (AU), Bosnia and Herzegovina (BA), Belgium (BE), Brazil (BR), Canada (CA), Chile (CL), China (CN), Colombia (CO), Costa Rica (CR), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Hungary (HU), Indonesia (ID), Ireland (IE), India (IN), Italy (IT), Jordan (JO), Japan (JP), Korea, Republic of (KR), Lebanon (LB), Morocco (MA), Monaco (MC), Montenegro (ME), Mexico (MX), Malaysia (MY), Netherlands (NL), Norway (NO), Nepal (NP), Peru (PE), Philippines (PH), Pakistan (PK), Poland (PL), Portugal (PT), Qatar (QA), Romania (RO), Serbia (RS), Russian Federation (RU), Saudia Arabia (SA), Singapore (SG), Slovakia (SK), Thailand (TH), Turkey (TR), Taiwan (TW), Viet Nam (VN), South Africa (ZA).
States: Arkansas California Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2035-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.