Z-1614-2018Class II

11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms

Name: Z-1614-2018 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
Creator: Ii - Vi Incorporated
Published: 2017-12-13
License: https://open.fda.gov/license/

Ii - Vi Incorporated / initiated 2017-12-13 / Terminated / root cause: design

FDA source

Ii - Vi Incorporated began a recall of 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms on 2017-12-13. FDA classified it as Class II and gives the reason as "Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1614-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-13
Posted: 2018-06-02
Terminated: 2020-04-22
Recalling firm: Ii - Vi Incorporated
Product: 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
Product code: N/A
Reason for recall: Affected diodes incorporated in the laser sights emitted greater than the 5 mW limit.
Root cause tag: design
FDA 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 in commerce: 323,972
Distribution: US Distribution to Oregon.
Product codes and lots: Model Numbers: 25-0655 & 25-0657

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1614-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1614-2018	Class II	Terminated	FDA Mandated	2018-06-13	2018-06-02

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)