Ultroid Technologies, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0783-2017)

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:

Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes

Product Classification:

Class II

Date Initiated: October 19, 2016
Date Posted: December 28, 2016
Recall Number: Z-0783-2017
Event ID: 75055
Reason for Recall:

Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)

Status: Terminated
Product Quantity: 62 units
Code Information:

ALL serial numbers and lot numbers sold since January 14, 2003.

Distribution Pattern:

AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated