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Single-Use Reprocessed Ultrasonic Surgical Instruments

FDA product code NLQ · Class U · Unknown

46
Registered devices
980
Adverse events
7
Recalls
27
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-09-24Stryker Sustainability SolutionsDue to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
2024-05-07MEDLINE INDUSTRIES, LP - NorthfieldPotential for an incomplete seal on the packaging tray.
2023-08-03MEDLINE INDUSTRIES, LP - NorthfieldVarious reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
2021-01-19Stryker Sustainability SolutionsProduct was distributed without receiving regulatory clearance.
2018-05-08Stryker Sustainability SolutionsStryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instr
2013-05-03Surgical Instrument Service And Savings, Inc.The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
2008-08-08Sterilmed IncSteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted becau

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.