Covidien Limited Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA
Brand
Covidien Limited
Lot Codes / Batch Numbers
4-070523-SP Battery Assembly 4-840120DIUU-US 4-070520-SP BPS
Products Sold
4-070523-SP Battery Assembly 4-840120DIUU-US 4-070520-SP BPS
Covidien Limited is recalling Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporati due to Wiring in battery back-up power supply may short and cause thermal damage to ventilator.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Wiring in battery back-up power supply may short and cause thermal damage to ventilator.
Recommended Action
Per FDA guidance
All customers were notified by Federal Express letter and were contacted by phone through field service engineers. They were told to examine their inventory for any installed or spare part battery assemblies and to remove and quarantine these parts. Any ventilators with installed affected battery assemblies were to be taken out of service.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026