Puritan Bennett Corporation Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
Brand
Puritan Bennett Corporation
Lot Codes / Batch Numbers
All units are subject to this notice (all serial numbers).
Products Sold
All units are subject to this notice (all serial numbers).
Puritan Bennett Corporation is recalling Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-K due to Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
Recommended Action
Per FDA guidance
Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.
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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026