Newport Laser Systems Recalled for Removable Safety Key Defect
Newport has recalled Class II laser systems because their key-actuated safety switch can be removed while the laser remains on, violating federal safety requirements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a laser safety mechanism with no reported injuries or illnesses. The risk is concrete—the key-actuated master control failure allows laser operation when the key is removed—but actual harm has not yet been reported.
Plain-English summary
Newport Corp is recalling N-LHP-928(j) laser head and power supply units, and N5-LPL-944-080 and N6-LPL-944-080 power supplies. A total of 19 affected units have been distributed in the United States.
The laser systems are designed with a key-actuated master control that must be removed to prevent laser operation. However, in the recalled units, the key can be removed from the key switch while the laser remains operational. This violates federal safety requirements under 21 CFR 1040.10(f)(4), creating a safety hazard.
Users who have purchased these products should discontinue use and contact Newport Corp for instructions on return or correction. The specific affected serial numbers are identified in the official FDA recall notice.
The recalled product
- Product
- Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
- Manufacturer
- Newport Corp
- Category
- Medical Device — Laser
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- P/N N-LHP-928 Set S/N (laser head + power supply): 6905AE
- 6907AE
- 9023AE
- 3148AF
- 6899AE 6909AE
- 9025AE
- 5695AF
- 5696AF
- 5691AF
- 5692AF
- 5693AF
- 23060079
Distribution
Distributed nationwide across the United States.
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