Data Foundry

Medical device recalls 2020

Oratect III Oral Fluid Drug Screen Device — Class II medical device recall Z-3041-2020

Terminated recall by Ameditech Inc, reported 2020-10-07, distributed nationwide. XXX

Recall numberZ-3041-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAmeditech Inc, San Diego, CA, United States
Recall initiated2020-08-18
Classified2020-09-30
Reported by FDA2020-10-07
Terminated2024-09-30
DistributedNationwide (US)
Countries outside the USAU, DE, ES, FR, NZ, SG
Quantity1,325 units

Product

Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ III Oral Fluid Drug Screen Device MET25+THC40+COC20+AMP25+OPI10+BZO5 "

Reason for recall

XXX

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-3041-2020. 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.