BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169

Recall Insight

This FDA Devices action (record #Z-1626-2021) was formally reported on June 2, 2021, with the manufacturer initiating the action on April 6, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Respironics, Inc. is listed as the recalling firm, operating out of Murrysville, PA. Federal records indicate 10 units units are affected.

The documented reason for this recall is: 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 potentia… Distribution data in the federal record shows the product reached: Distribution US nationwide to states of: LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN. Brazil, China, and Japan. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.