🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: March 27, 2024 Newport Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    P/N N-LHP-928 Set S/N (laser head + power supply): 6905AE, 6907AE, 9023AE, 3148AF, 6899AE 6909AE, 9025AE, 5695AF, 5696AF, 5691AF, 5692AF, 5693AF, 5694AF (9 of them in Irvine warehouse) P/N: N6-LPL-944-080 Power supply S/N: 23060081, 23060079
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Newport Corp
Reason for Recall:
According to 21 CFR 1040.10(f)(4), 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. However, the key of the subject laser products can be removed from key switch and the laser remains on. This is a safety concern.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

P/N N-LHP-928 Set S/N (laser head + power supply): 6905AE, 6907AE, 9023AE, 3148AF, 6899AE 6909AE, 9025AE, 5695AF, 5696AF, 5691AF, 5692AF, 5693AF, 5694AF (9 of them in Irvine warehouse) P/N: N6-LPL-944-080 Power supply S/N: 23060081, 23060079

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1946-2024