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Puritan Bennett Corp.

Also registered as Puritan-Bennett

Country not established

Devices
114
FDA recalls
2

What Puritan Bennett Corp. makes

The company manufactures respiratory support devices, including proportional solenoid valves for ventilator control, portable liquid oxygen systems, and oxygen concentrators with integrated oxygen conservation features. It also produces nasal CPAP systems, diagnostic respiratory support platforms, microprocessor-controlled ventilators, manual resuscitators for infants, and patient monitoring devices for vital signs. Additional offerings include patient circuits for portable ventilators and standalone respiratory support systems.

These devices are regulated under the FDA’s 510(k) pathway, with most classified as Class I or Class II medical devices. The portfolio is listed in the FDA’s 510(k) clearance registry, and the company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue114

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FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Puritan Bennett Corp., the earliest on 2005-04-20 and the most recent on 2006-08-31. By recorded status: 2 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2006

    • 31 Aug 2006 Z-0444-2007 Unclassified (pre-2012) Terminated 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. Distribution: Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada,…
      Full distribution text Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.
      Submission number: K003075

  • 2005

    • 20 Apr 2005 Z-1085-05 Unclassified (pre-2012) Terminated Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection. Distribution: USA, Canada and Europe. Submission number: K970460