CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
N-lhp-928, HeNe Laser System, 35 mW recalled by Pacific Lasertech
Pacific Lasertech is recalling N-lhp-928, HeNe Laser System, 35 mW, distributed nationwide in the US. The recall was initiated on 1 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2977-2024
- FDA event ID
- 95290
- Recalling firm
- Pacific Lasertech, San Marcos, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2024
- FDA classified
- 10 Sep 2024
- Reported
- 18 Sep 2024
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Mar 2024 | Recall initiated by company | |
| 10 Sep 2024 | Classified by FDA | +193 days |
| 18 Sep 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
N-LHP-928, HeNe Laser System, 35 mW
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is N-lhp-928, HeNe Laser System, 35 mW recalled?
Yes. Pacific Lasertech recalled N-lhp-928, HeNe Laser System, 35 mW on 1 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-2977-2024.
Why was it recalled?
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.
Which lots are affected?
N-LHP-928
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pacific Lasertech
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 25-LHP-828, HeNe Laser System, 35 mW recalled by Pacific Lasertech | Pacific Lasertech | Device Malfunction | Nationwide |
| Device | CLASS II | 25-LHP-928, HeNe Laser System, 25 mW recalled by Pacific Lasertech | Pacific Lasertech | Device Malfunction | Nationwide |
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