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.
- Hazard
- optical-fiber-damage
- burn-injury-risk
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22