Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2280-2026Class II

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

Fresh Roast Systems Inc / initiated 2026-04-15 / Open, Classified / root cause: manufacturing process

Fresh Roast Systems Inc began a recall of Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2280-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Fresh Roast Systems Inc
Product
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
Product code
RDW General Purpose Laser Products
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.
Root cause tag
manufacturing process
FDA root cause
Radiation Control for Health and Safety Act
Action
Fresh Roast Safety, Inc. sent Safety Notice to owners and users of the ColorTrack roasting sensor Model Number 'BENCH R-100' manufactured by Fresh Roast Systems, Inc.
Quantity in commerce
38
Distribution
U.S.
Product codes and lots
Only Model Number provide. Model Number: BENCH R-100

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2280-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2280-2026Class IIOngoingFDA Mandated