The Recall Desk
SevereFDA (Devices)·Z-1625-2021·Announced 2021-06-02

Philips Respironics BiPAP V30 Auto Recall for Non-Conforming Plastic Material

Philips Respironics is recalling 22 BiPAP V30 Auto ventilators because non-conforming plastic in motor assemblies may cause toxic off-gassing or sudden device failure.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of asphyxia due to sudden device failure, which aligns with the rubric criteria for Severe severity involving significant injury potential.

Plain-English summary

Philips Respironics, Inc. is recalling 22 units of the BiPAP V30 Auto continuous ventilator, non-life-supporting (Material Number: 1111178). The recall was initiated because certain devices were built with motor assemblies that could contain non-conforming plastic material.

This defect presents two primary hazards: exposure to off-gassing of Volatile Organic Compounds (VOCs) not normally present, which creates a potential biosafety or toxicological hazard, and the potential for sudden failure of the device. A sudden failure could result in a Ventilator Inoperative condition, posing a risk of asphyxia if the issue is not immediately identified and addressed by the care provider.

The affected devices were distributed nationwide in the United States to the states of Louisiana, Pennsylvania, Wisconsin, Colorado, West Virginia, Washington, California, Texas, Missouri, Oklahoma, Florida, and Tennessee. The devices were also distributed in Brazil, China, and Japan. Specific serial numbers for the affected units are listed in the official recall record.

The recalled product

Product
BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
22

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)

  • Serial Number: N3059246815B4
  • N305925228752
  • N30592449378D
  • N3059251913E9
  • N30592514C80C
  • N30592513BCB3
  • N30592515D985
  • N305924084164
  • N305925119FA1
  • N30592516EB1E
  • N305925180260
  • N30592457C72B
  • N306372301F1F
  • N306372551C62
  • N30637223345C
  • N30592416B1C2
  • N30592524E264
  • N30592520A440
  • N3059252396DB
  • N30592517FA97

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · Philips Respironics, Inc.

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Same hazard · toxic off gassing

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