Data Foundry

Medical device recalls 2026

Fresh Roast Systems ColorTrack — Class II medical device recall Z-2280-2026

Ongoing recall by Fresh Roast Systems Inc, reported 2026-06-17. A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number

Recall numberZ-2280-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedFDA mandated
Recalling firmFresh Roast Systems Inc, Key Biscayne, FL, United States
Recall initiated2026-04-15
Classified2026-06-11
Reported by FDA2026-06-17
Quantity38

Product

Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100

Reason for recall

A defect has been identified in the manufacture of the Fresh Roast Systems ColorTrack instrument model number BENCH R-100 which could under very rare specific misuse circumstances potentially allow human access to infrared laser light levels in excess of the safety Classification of the product.

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-2280-2026. 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.