PACIFIC LASERTECH, LLC: Medical Device Recall in 2024 - (Recall #: Z-2975-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 1, 2024

Date Posted: September 18, 2024

Recall Number: Z-2975-2024

Event ID: 95290

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.

Status: Ongoing

Product Quantity: 4

Code Information:

25-LHP-828

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

FDA Mandated