Ultroid Technologies, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0784-2017)

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 Procedure Pack including the Ultroid Sterile Disposable Probes.

Product Classification:

Class II

Date Initiated: October 19, 2016

Date Posted: December 28, 2016

Recall Number: Z-0784-2017

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: 52,084

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