Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling 12 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.
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: The recall involves a risk-of-harm product (surgical lights) where the hazard (particle contamination leading to infection) has not yet been reported as an actual injury or illness, fitting the 'High' severity criteria for theoretical risks in medical devices.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 12 units of the Maquet VOLISTA StandOP Surgical Lights (Product Code: ARDVST229002A, Model: VST66SF AIM). The recall involves specific serial numbers ranging from 500005 to 500028. The affected units were distributed worldwide, including in the United States and numerous international locations.
The recall is being conducted because the coating on the light head forks of the surgical lights may crack. This defect poses a risk of particles falling into the surgical field during surgery, which may result in patient infection. The source text does not report any specific illnesses or injuries associated with this defect.
Healthcare facilities and users of the affected surgical lights should stop using the units and contact Maquet Cardiovascular US Sales, LLC for instructions on how to proceed with the recall.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 12
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Maquet Cardiovascular Us Sales, Llc 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 13 products in this recall →Related recalls
Same manufacturer · Maquet Cardiovascular Us Sales, Llc
See all →- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches
FDA (Devices) · 2020-12-23
- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
FDA (Devices) · 2020-12-23
- HighMaquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance
FDA (Devices) · 2020-11-18
- HighMaquet Yuno Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
- HighMaquet Yuno II Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
Same hazard · contamination
See all →- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
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