The Recall Desk

Manufacturer

Custom Ultrasonics, Inc.

2 recalls in our database name Custom Ultrasonics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2016-07-13

Of the 2 recalls from Custom Ultrasonics, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2130-2016·2016-07-13

    Custom Ultrasonics System 83 Plus Endoscope Washer Recall Issued

    Custom Ultrasonics is recalling System 83 Plus endoscope washer/disinfectors to warn customers not to use them for duodenoscopes until further notice.

    Product
    The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2014·2013-12-04

    Custom Ultrasonics Endoscope Washer/Disinfector Recalled for Incomplete Validation

    Custom Ultrasonics is recalling 118 System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector units because they were not fully validated prior to distribution.

    Product
    Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
    Category
    Medical Device
    Distribution
    Distributed nationwide