FDA Medical Device Recalls (openFDA)
Crimson Trace Corporation: Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
- Recall number
- Z-1361-2018
- Recalling firm
- Crimson Trace Corporation
- Product
- Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
- Status
- Terminated
- Initiated
- 2017-10-10
- Posted
- 2018-04-23
- Terminated
- 2019-11-22
- Reason
- A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Crimson Trace Corporation (CTC) will bring defect into compliance: 1.CTC will send notification letters or emails to all relevant dealers, distributors, and purchasers, 2.CTC will provide return merchandise authorization numbers and shipping labels to all relevant dealers, distributors, and purchasers, 3.CTC will replace all returned product units with compliant diodes, 4.The corrections will be conducted at no cost to the purchaser, and 5.The corrective action will be completed by January 31, 2019. For further questions, please call (800) 442-2406.
- Quantity
- 184,390
- Distribution
- USA (nationwide) Distribution
- Lot, serial or model codes
- Model No. CTC with Laser Sights.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- REU
- Firm FEI
- 3000222719
- Firm city
- Wilsonville
- Firm state
- OR
- 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