Data Foundry

Medical device recalls 2016

Ultroid Mobile Generator/Battery operated unit including the Ultroid… — Class II medical device recall Z-0783-2017

Terminated recall by Ultroid Technologies, Inc., reported 2016-12-28, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quali

Recall numberZ-0783-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmUltroid Technologies, Inc., Tampa, FL, United States
Recall initiated2016-10-19
Classified2016-12-17
Reported by FDA2016-12-28
Terminated2019-12-11
DistributedAL, 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, PR, RI, SC, TN, TX, UT, VA, WA
Countries outside the USAE, AU, CL, ES, GB, GR, HK, ID, IN, IQ, JP, KW, MX, MY, NG, QA, RU, SI, TR, TT, VN
Quantity62 units

Product

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

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)

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0783-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.