FDA Medical Device Recalls (openFDA)
Ii - Vi Incorporated: 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
- Recall number
- Z-1614-2018
- Recalling firm
- Ii - Vi Incorporated
- Product
- 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
- Status
- Terminated
- Initiated
- 2017-12-13
- Posted
- not on file
- Terminated
- 2020-04-22
- Reason
- Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.
- Root cause
- Device Design
- Action
- Please note that II-VI Inc. is responsible for the correction of all noncompliant products should the reported epoxy processing defect adversely affect any other laser diodes manufactured by II-VI, Inc. The single customer, Crimson Trace Corporation CTC was formally notified by you in writing. The defective laser diodes, models 25-0655 & 25-0657 will be or have already been replaced at no cost to CTC. The replacement will be done in batches and is expected to take approximately six to nine months, or no later than January 31, 2019. Defective laser diodes will be either returned to II-VI or destroyed at CTC. For further questions, please call (724) 352-4455.
- Quantity
- 323,972
- Distribution
- US Distribution to Oregon.
- Lot, serial or model codes
- Model Numbers: 25-0655 & 25-0657
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3004940116
- Firm city
- Saxonburg
- Firm state
- PA
- 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