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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-2280-2026
Recalling firm
Fresh Roast Systems Inc
Product
Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100
Status
Open, Classified
Initiated
2026-04-15
Posted
2026-06-11
Terminated
not on file
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.
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
38
Distribution
U.S.
Lot, serial or model codes
Only Model Number provide. Model Number: BENCH R-100
510(k) numbers
not on file
PMA numbers
not on file
Product code
RDW
Firm FEI
3008254664
Firm city
Key Biscayne
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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