FDA Medical devices recall ·
Fresh Roast Systems ColorTrack recall
- Recall number
- Z-2280-2026
- Date
- (initiated April 15, 2026)
- Company / brand
- Fresh Roast Systems Inc
200 Ocean Lane Dr Apt 806, Key Biscayne, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 38
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Only Model Number provide. Model Number: BENCH R-100
Distribution
U.S.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2280-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.