FDA Medical Device Recalls (openFDA)
Custom Ultrasonics, Inc.: 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.
- Recall number
- Z-2130-2016
- Recalling firm
- Custom Ultrasonics, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-05-06
- Posted
- 2016-07-06
- Terminated
- 2017-04-18
- Reason
- 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.
- Root cause
- Process control
- Action
- Custom Ultrasonics, Inc. sent an Urgent Medical Device Recall letter dated May 6, 2016, to all affected customers. The letter advised customers not to use the System 83 Plus AERs for cleaning and/or high-level disinfection of duodenoscopes until further notice. In addition, they sent a warning label for customers to affix in a prominent location on the System 83 Plus AER's on or before June 3, 2016 stating the following: "This device is not indicated for reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing options, please contact the duodenoscope manufacturer." For questions regarding this recall call 215-364-1477.
- Quantity
- 2,345 units
- 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, 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.
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NVE
- Firm FEI
- 2523209
- Firm city
- Ivyland
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28