Philips Respironics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1625-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178

Product Classification:

Class II

Date Initiated: April 6, 2021

Date Posted: June 2, 2021

Recall Number: Z-1625-2021

Event ID: 87753

Reason for Recall:

Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.

Status: Terminated

Product Quantity: 22 units

Code Information:

Serial Number: N3059246815B4, N305925228752, N30592449378D, N3059251913E9, N30592514C80C, N30592513BCB3, N30592515D985, N305924084164, N305925119FA1, N30592516EB1E, N305925180260, N30592457C72B, N306372301F1F, N306372551C62, N30637223345C, N30592416B1C2, N30592524E264, N30592520A440, N3059252396DB, N30592517FA97, N3059241492D0, N30592512AD3A.

Distribution Pattern:

Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan

Voluntary or Mandated:

Voluntary: Firm initiated