Recall Z-2280-2026— Fresh Roast Systems Inc
Class II · Ongoing
Class II FDA medical device recall by Fresh Roast Systems Inc, initiated 2026-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Fresh Roast Systems Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-15
- Firm location
- Key Biscayne, FL, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.