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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the defect results in the device failing to operate (producing an error) rather than causing a safety hazard or injury.
Plain-English summary
Xintec Corp is recalling 45 units of OptiLITE, Products for Laser Surgery, Model # CGH1080F. These are 800 micron single-use holmium fiber assemblies with flat tips, identified by Lot Number 21144 and UDI 00855430006036. The devices were sterilized by Sterrad Run 4149 and have a use-by date of 08/10/2021.
The recall was initiated because the fiber lasers in this lot were programmed incorrectly. As a result, the fibers will produce an error message and will not allow the user to operate the laser when plugged in. This is a functional defect that prevents the device from performing its intended function.
The affected units were distributed in Pennsylvania (PA) and Virginia (VA). Users of these specific laser fiber assemblies should stop using them and contact Xintec Corp for further instructions.
The recalled product
- 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
- Manufacturer
- Xintec Corp
- Hazard
- Affected units
- 45
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 (2)
- Lot # 21144
- Use by 08/10/2021
Distribution
Related recalls
Same manufacturer · Xintec Corp
See all →- ModerateXintec OptiLITE Laser Surgery Fibers Recalled for Reprocessing Instruction Deficiencies
FDA (Devices) · 2017-08-09
Same hazard · malfunction
See all →- ModerateCriticare nGenuity Patient Monitor Recalled for Capnography Setup Error
FDA (Devices) · 2026-09-30
- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- ModerateOlympus 4K UHD LCD Monitors Recalled Due to Potential Connector Faults
FDA (Devices) · 2026-07-29
- High
- ModeratePhilips Azurion 3M15 Medical Imaging Systems Recalled Due to Software Issue
FDA (Devices) · 2026-06-10
Similar recalls
- ModerateXintec OptiLITE Laser Surgery Fibers Recalled for Reprocessing Instruction Deficiencies
FDA (Devices) · 2017-08-09
- SevereLeoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals
FDA (Devices) · 2018-12-19
- HighUnimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
FDA (Devices) · 2012-09-05
- HighLeoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
FDA (Devices) · 2018-12-19
- HighQuanta System Sterile Optical Laser Fiber Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-06-16
- ModerateCook Inc. Recalls OptiLite Multi-Use Holmium Laser Fibers Due to Reprocessing Instructions
FDA (Devices) · 2017-06-21