Z-1361-2018Class II

Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used...

Name: Z-1361-2018 Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used...
Creator: Crimson Trace Corporation
Published: 2017-10-10
License: https://open.fda.gov/license/

Crimson Trace Corporation / initiated 2017-10-10 / Terminated

FDA source

Crimson Trace Corporation began a recall of Crimson Trace Corporation laser sights. The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition on 2017-10-10. FDA classified it as Class II and gives the reason as "A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1361-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-10
Posted: 2018-04-23
Terminated: 2019-11-22
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.
Product code: REU Laser Aiming Product, Visible
Reason for recall: A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW.
FDA 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 in commerce: 184,390
Distribution: USA (nationwide) Distribution
Product codes and lots: Model No. CTC with Laser Sights.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1361-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1361-2018	Class II	Terminated	FDA Mandated	2018-05-02	2018-04-23

Product code REU

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)