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Custom Ultrasonics, Inc.

Also registered as Custom Ultrasonics

United StatesFDA 510(k) applicant, unverified

Devices
6
FDA recalls
4

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Custom Ultrasonics, Inc. makes

Custom Ultrasonics, Inc. manufactures medical device systems for reprocessing surgical instruments, including the Scope-Assist Flushing Sink—a device for cleaning endoscopes—and the System 83 Plus Washer/Disinfector, which automates instrument washing and disinfection.

These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company operates from the United States.

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

Catalogue6

Newest first, rows 1-6 of 6

FDA recalls4

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

FDA recall records list 4 recalls initiated by Custom Ultrasonics, Inc., the earliest on 2005-12-12 and the most recent on 2016-05-06. By recorded status: 4 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.

  • 2016

    • 6 May 2016 Z-2130-2016 Class II Terminated To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. Distribution: Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI,…
      Full distribution text Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.

  • 2013

    • 12 Mar 2013 Z-0426-2014 Class II Terminated Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. Distribution: Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru. Submission numbers: K122172, K983017

  • 2008

    • 11 Feb 2008 Z-1182-2008 Unclassified (pre-2012) Terminated Inadvertent selection of the "wash" cycle Distribution: Worldwide; USA medical facilities and physicians and Canada Submission number: K983017

  • 2005

    • 12 Dec 2005 Z-0770-2007 Unclassified (pre-2012) Terminated The device was marketed without a 510k Distribution: Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK. Submission number: K061430

Frequently asked questions

How many devices does Custom Ultrasonics, Inc. have in the registry?

The registry currently lists 6 devices for Custom Ultrasonics, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Custom Ultrasonics, Inc.'s devices?

Among its 6 most recently registered devices, Custom Ultrasonics, Inc. has devices listed in FDA 510(k) (6 devices).

What risk classes do Custom Ultrasonics, Inc.'s devices fall under?

Among its 6 most recently registered devices, the classes recorded for Custom Ultrasonics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Custom Ultrasonics, Inc.?

FDA recall records list 4 recalls initiated by Custom Ultrasonics, Inc., the most recent initiated on 2016-05-06. 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 Custom Ultrasonics, Inc. in the registry?

The most recently registered devices listed for Custom Ultrasonics, Inc. include Scope-Assist Flushing Sink, MODIFICATION TO SYSTEM 83 PLUS, CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2 and SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR.

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