The Recall Desk

Manufacturer

Xintec Corp

2 recalls in our database name Xintec Corp as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-10-30

Of the 2 recalls from Xintec Corp we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • LowFDA (Devices)·Z-0162-2020·2019-10-30

    Xintec OptiLITE Laser Fiber Assembly Recall Due to Programming Error

    Xintec Corp is recalling 45 OptiLITE laser fiber assemblies because they were programmed incorrectly. The devices will produce an error and prevent laser use.

    Product
    OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2866-2017·2017-08-09

    Xintec OptiLITE Laser Surgery Fibers Recalled for Reprocessing Instruction Deficiencies

    Xintec Corp is recalling OptiLITE laser surgery products because reprocessing instructions may not meet new standards for cleaning and sterilization.

    Product
    OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is
    Category
    Medical Device
    Distribution
    Distributed nationwide