Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit… — Class II medical device recall Z-0782-2017
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 number | Z-0782-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultroid Technologies, Inc., Tampa, FL, United States |
| Recall initiated | 2016-10-19 |
| Classified | 2016-12-17 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2019-12-11 |
| Distributed | 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 |
| Countries outside the US | AE, AU, CL, ES, GB, GR, HK, ID, IN, IQ, JP, KW, MX, MY, NG, QA, RU, SI, TR, TT, VN |
| Quantity | 1,129 |
Product
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile 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-0782-2017. 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.