# FDA recall Z-2035-2025

> **Philips Respironics, Inc.** · Class I · device recall initiated 2025-05-09.

## Product

BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.

## Reason for recall

This device does not indicate for use in patients with respiratory failure.

## 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).

## Key facts

- **Recall number:** Z-2035-2025
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-09
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Murrysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2025

## Citation

> AI Analytics. FDA recall Z-2035-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2035-2025. Source: US FDA. Licensed CC0.

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