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Getinge USA, Inc.

United StatesFDA applicant, unverified

Devices
4
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Getinge USA, Inc. makes

Getinge USA, Inc. produces steam sterilizers and biological indicators, including the MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER, BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, BIOSIGN STEAM-24 BIOLOGICAL INDICATOR, and SPOR-TEST PA BIOLOGICAL INDICATOR KIT.

These devices are Class II and listed in the FDA 510(k) registry. The company is based in the US.

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

Catalogue4

Newest first, rows 1-4 of 4

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Getinge USA, Inc., the earliest on 2012-05-25 and the most recent on 2013-08-02. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination, electrical or power, mechanical integrity, performance or accuracy and 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.

  • 2013

    • 2 Aug 2013 Z-1994-2013 Class II Terminated AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters. Distribution: Worldwide Distribution - USA and the country of Canada. Submission number: K093794

  • 2012

    • 25 May 2012 Z-2079-2012 Class II Terminated Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heated 9100-Series manufactured between 2009-05-04 through 09-26-2011. This action is based on a report from the ground fault breaker manufacturer of a production error. Distribution: Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of…
      Full distribution text Worldwide Distribution - USA including Maryland, Indiana, New Mexico, Massachuesetts, Texas, Kansas and the country of Canada

Frequently asked questions

How many devices does Getinge USA, Inc. have in the registry?

The registry currently lists 4 devices for Getinge USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Getinge USA, Inc.'s devices?

Among its 4 most recently registered devices, Getinge USA, Inc. has devices listed in FDA 510(k) (4 devices).

What risk classes do Getinge USA, Inc.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Getinge USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Getinge USA, Inc.?

FDA recall records list 2 recalls initiated by Getinge USA, Inc., the most recent initiated on 2 Aug 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Getinge USA, Inc. in the registry?

The most recently registered devices listed for Getinge USA, Inc. include MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER, BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, BIOSIGN STEAM-24 BIOLOGICAL INDICATOR and SPOR-TEST PA BIOLOGICAL INDICATOR KIT.

Generated automatically from registry data and not verified by a human reviewer.