FDA Device recall Z-0783-2017
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes by Ultroid Technologies, citing products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, stan….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0783-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-19 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ultroid Technologies |
| Distribution | 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, PR, RI, SC, TN, TX, UT, VA, WA |
Product
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Reason
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)
Identifiers
| code_info | ALL serial numbers and lot numbers sold since January 14, 2003. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0783-2017%22
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