VS3 Iridium Visionsense Beam Combiner Optical Fiber Cable Damage Risk
Visionsense VS3 Iridium beam combiners may develop damaged optical fiber cables through handling or bending, causing loss of functionality and potential cable heating or melting. Affected units were distributed nationwide in the US.
What this means for you
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 an FDA Class II recall for optical fiber cable damage that may cause heating and melting, presenting a burn risk. No injuries have been reported, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' resulting in a High severity score.
Plain-English summary
The Visionsense VS3 Iridium Visionsense Infrared Fluorescence Light Integrator (Beam Combiner), Product Number 161-0001, is being recalled due to potential damage to the product's optical fiber cable.
The optical fiber cable can become damaged through normal handling or bending during use, which may result in loss of functionality and heating or melting of the outer cable surface.
A total of 111 units were distributed within the United States on a nationwide basis, and 93 units were distributed outside the United States. The affected product includes multiple lot numbers and serial numbers as documented in the FDA recall notice.
The recalled product
- Product
- VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
- Manufacturer
- Visionsense, Ltd.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Visionsense, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Visionsense, Ltd.
See all →- ModerateMedical device recall: VS3 Iridium infrared fluorescence microscope
FDA (Devices) · 2022-11-30
- HighVisionsense Infrared Microscope Recalled Due to Optical Fiber Cable Damage
FDA (Devices) · 2022-11-30
Other medical device recalls
- HighMedline Recalls Neonatal Heated Wire Breathing Circuits Due to Thermal Damage
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02