CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number recalled
Fresh Roast Systems is recalling Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number. The recall was initiated on 15 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2280-2026
- FDA event ID
- 99111
- Recalling firm
- Fresh Roast Systems, Key Biscayne, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Apr 2026
- FDA classified
- 11 Jun 2026
- Reported
- 17 Jun 2026
- Type
- FDA Mandated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 15 Apr 2026 | Recall initiated by company | |
| 11 Jun 2026 | Classified by FDA | +57 days |
| 17 Jun 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
Where it was distributed
U.S.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Only Model Number provide. Model Number: BENCH R-100
Where was it sold?
U.S.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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