Alcon Recalls LuxOR Ophthalmic Microscope Floor Stands Due to Caster Defect
Alcon is recalling 1,074 LuxOR microscope floor stands because casters may break or detach from the base after impact or stress.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves a structural component (caster) that could break or detach, posing a risk of harm in a surgical setting, although no injuries have been reported.
Plain-English summary
Alcon Research, Ltd. is recalling 1,074 units of the LX3 Floor Stand for LuxOR Ophthalmic Microscope and the Endure LuxOR Q-VUE Ophthalmic Microscope. These floor stands are used in combination with LuxOR ophthalmic microscopes for low magnification visualization during cataract, retina, and cornea surgeries. The affected units were distributed worldwide, including the United States, Puerto Rico, and numerous international countries.
The recall was initiated because multiple shipments or forceful impact to a caster on the LuxOR/LX3 microscope may stress the microscope base. This stress could contribute to a caster breaking or detaching from the base. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Alcon Research, Ltd. is the recalling firm and is responsible for managing the recall process for these devices.
The recalled product
- Product
- LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D…
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 1,074
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 (20)
- Domestic Serial Numbers: 1402548501X
- 1402548502X
- 1402548503X
- 1402548504X
- 1402548505X
- 1402548506X
- 1402577401X
- 1402577402X
- 1402577403X
- 1402577404X
- 1402577405X
- 1402577406X
- 1402612001X
- 1402612002X
- 1402612003X
- 1402612004X
- 1402612005X
- 1402612006X
- 1402655703X
- 1402655704X
Distribution
Related recalls
Same manufacturer · Alcon Research, Ltd.
See all →- SevereLegion FMS Pak Surgical Instruments Recalled for Patient Injury from Plastic Debris
FDA (Devices) · 2023-08-23
- SeverePhaco Standalone Tips Recalled Due to Plastic Debris Risk
FDA (Devices) · 2023-08-23
- HighCenturion FMS Pak Recalled Due to Patient Injury Risk from Plastic Debris
FDA (Devices) · 2023-08-23
- SevereAlcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk
FDA (Devices) · 2023-08-23
- SevereAlcon Constellation Procedure Pak recalled due to plastic debris risk
FDA (Devices) · 2023-08-23
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- ModerateAlcon Recalls LX3 Microscope Floor Stands Due to Cabling Issues
FDA (Devices) · 2015-09-02
- HighAlcon Ophthalmic Microscope Recalled for Potential Optical Head Detachment
FDA (Devices) · 2019-03-06
- HighPhilips Allura Xper F020 DR Table Recall for Monitor Suspension Defect
FDA (Devices) · 2018-10-03
- HighPhilips Allura Xper F010 DR Table Recall for Monitor Detachment Risk
FDA (Devices) · 2018-10-03
- SevereSiemens Artis zee X-Ray Systems Recalled for Ceiling Support Screw Failure
FDA (Devices) · 2019-07-10
- SevereSiemens Artis X-Ray Systems Recalled for Ceiling Support Screw Failure
FDA (Devices) · 2019-07-10