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Getinge/Castle, Inc.

United StatesFDA applicant, unverified

Devices
9
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Getinge/Castle, Inc. makes

The company manufactures steam sterilizers, including gravity/vacuum and powered models like the Series 100, Series 200 (PowerClave), 233HC, 400HC/500HC, and 733HC, as well as straight-line steam sterilizers. It also produces surgical lights, such as the Castle Surgical Light (Model 3000) and the OptiView Series, and peracetic acid biological indicator kits for sterilization validation.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.

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

Catalogue9

Newest first, rows 1-9 of 9

FDA recalls1

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

FDA recall records list 1 recall initiated by Getinge/Castle, Inc., initiated on 2003-03-25. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. 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.

  • 2003

    • 25 Mar 2003 Z-0908-03 Unclassified (pre-2012) Terminated Hot water may splash from the washer chamber creating a burn hazard. Distribution: Nationwide. Medical facilities in AL, CA, CO, LA, MA, MI, MN, MO, NC, NH, NM, OK, PA, TX, WA, and WI. Submission number: K920413

Frequently asked questions

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

The registry currently lists 9 devices for Getinge/Castle, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Getinge/Castle, Inc.'s devices?

Among its 9 most recently registered devices, Getinge/Castle, Inc. has devices listed in FDA 510(k) (9 devices).

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

Among its 9 most recently registered devices, the classes recorded for Getinge/Castle, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Getinge/Castle, Inc.?

FDA recall records list 1 recall initiated by Getinge/Castle, Inc., the most recent initiated on 25 Mar 2003. 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/Castle, Inc. in the registry?

The most recently registered devices listed for Getinge/Castle, Inc. include CASTLE MODEL 233HC STEAM STERILIZER, CASTLE PERACETIC ACID BIOLOGICAL INDICATOR KIT, CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC and CASTLE SURGICAL LIGHT, MODEL 3000.

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