Recall Ledger

Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100 recall (Fresh Roast Systems Inc)

Medical deviceClass IIOngoing

Summary: Fresh Roast Systems Inc is recalling Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100. Reason: 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.

What is being recalled

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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

U.S.

How to tell if yours is affected

Only Model Number provide. Model Number: BENCH R-100

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2280-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedApril 15, 2026
ReportedJune 17, 2026
CompanyFresh Roast Systems Inc
Company locationKey Biscayne, FL, United States
Initiated byFDA Mandated
Quantity38

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