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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

PACIFIC LASERTECH, LLC: HeNe Laser Systems Recalled Due to Safety Key Control Defect

Agency Publication Date: September 10, 2024
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Summary

Pacific Lasertech, LLC is recalling approximately 40 units of HeNe Laser Systems, including models 25-LHP-828, 25-LHP-928, and N-LHP-928. These high-powered laser products (Class IIIb and IV) have a safety defect where the control key can be removed while the device is switched on, failing to meet federal safety standards. This defect could allow the laser to remain active and potentially be operated by unauthorized individuals without the key. The manufacturer is correcting the issue by replacing the faulty key switches with a version that correctly captures the key while in the 'on' position.

Risk

The ability to remove the master control key while the laser is active bypasses a critical safety mechanism designed to prevent unauthorized or accidental operation. This increases the risk of accidental laser exposure, which can lead to serious and permanent eye or skin injuries.

What You Should Do

  1. Identify if you have an affected laser system by checking the model number on the device label. Affected models include 25-LHP-828, 25-LHP-928, and N-LHP-928.
  2. Verify the specific laser power rating and identification code: Model 25-LHP-828 (35 mW), Model 25-LHP-928 (25 mW), or Model N-LHP-928 (35 mW).
  3. Contact Pacific Lasertech, LLC immediately to arrange for the required replacement of the key switch to ensure it captures the key when in the 'on' position.
  4. Contact your healthcare provider or the manufacturer for further instructions regarding safe usage or to inquire about potential refunds or service appointments.
  5. For additional information or questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

You have 2 options:

๐Ÿ”งOption 1: Free Repair

Replacement with a key switch that captures the key when in the on position.

How to: Contact the manufacturer to receive a corrected key switch replacement.
๐Ÿ“‹Option 2: Other Action

Professional consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: 25-LHP-828, HeNe Laser System, 35 mW
Model / REF:
25-LHP-828
Lot Numbers:
25-LHP-828
Product: 25-LHP-928, HeNe Laser System, 25 mW
Model / REF:
25-LHP-928
Lot Numbers:
25-LHP-928
Product: N-LHP-928, HeNe Laser System, 35 mW
Model / REF:
N-LHP-928
Lot Numbers:
N-LHP-928

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95290
Status: Active
Manufacturer: PACIFIC LASERTECH, LLC
Manufactured In: United States
Units Affected: 3 products (4; 4; 32)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.