Data Foundry

Medical device recalls 2018

iTOVi Tracker/Scanner — Class II medical device recall Z-2736-2018

Terminated recall by Hudson Scientific LLC, reported 2018-08-15, distributed nationwide. The device and its accessories may not have been manufactured according to current Good Manufacturing Practice

Recall numberZ-2736-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHudson Scientific LLC, Hudson, MI, United States
Recall initiated2018-07-02
Classified2018-08-08
Reported by FDA2018-08-15
Terminated2020-01-13
DistributedNationwide (US)
Quantity35,949 units
Reason classescgmp
Lot numbers012016, 012017, 012018, 022017, 032016, 032017, 092017, 112016, 112017, 122016
Serial numbers949MAC
Model numbersITS10, ITS15

Product

iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.

Reason for recall

The device and its accessories may not have been manufactured according to current Good Manufacturing Practices. In addition, the firm has received three complaints regarding electric shocks received when using the device.

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-2736-2018. 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.