Custom Ultrasonics, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2130-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 6, 2016

Date Posted: July 13, 2016

Recall Number: Z-2130-2016

Event ID: 74311

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2,345 units

Code Information:

All serial numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated