Z-2975-2024Class II

25-LHP-828, HeNe Laser System, 35 mW

Name: Z-2975-2024 25-LHP-828, HeNe Laser System, 35 mW
Creator: Pacific Lasertech, Llc
Published: 2024-03-01
License: https://open.fda.gov/license/

Pacific Lasertech, LLC / initiated 2024-03-01 / Open, Classified

FDA source

PACIFIC LASERTECH, LLC began a recall of 25-LHP-828, HeNe Laser System, 35 mW on 2024-03-01. FDA classified it as Class II and gives the reason as "These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2975-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-01
Posted: 2024-09-10
Recalling firm: Pacific Lasertech, LLC
Product: 25-LHP-828, HeNe Laser System, 35 mW
Product code: RDW General Purpose Laser Products
Reason for recall: These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.
FDA root cause: Radiation Control for Health and Safety Act
Action: The firm notified all purchasers of the defect. Customers were instructed to return all units for replacement of the switch free of charge.
Quantity in commerce: 4
Distribution: US Nationwide Distribution
Product codes and lots: 25-LHP-828

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2975-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2975-2024	Class II	Ongoing	FDA Mandated	2024-09-18	2024-09-10
Z-2976-2024	Class II	Ongoing	FDA Mandated	2024-09-18	2024-09-10
Z-2977-2024	Class II	Ongoing	FDA Mandated	2024-09-18	2024-09-10

Product code RDW

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)