Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk
Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.
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 involves a risk-of-harm product (potential patient infection) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling two units of the Maquet VOLISTA StandOP Surgical Lights, Model VLT600SF AIM STP. The affected units have serial numbers 21001 and 21002. These devices were distributed worldwide, including in the United States and numerous other countries.
The recall is due to a potential defect where the coating on the light head forks may crack. This defect poses a risk of particles falling into the surgical field during surgery, which may result in patient infection.
Healthcare facilities should stop using the affected surgical lights and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 2
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)
- Serial Numbers: 21001
- 21002
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 II Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
- HighMaquet Yuno Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- SevereMaquet VOLISTA StandOP Surgical Light Recall for Detachment Risk
FDA (Devices) · 2018-07-25
- HighMaquet Recalls VOLISTA StandOP Surgical Lights Due to Keypad Failure Risk
FDA (Devices) · 2018-06-06
- HighSurgical Light Paint Particles May Fall Into Operating Field
FDA (Devices) · 2022-07-06
- HighGetinge Recalls VOLISTA StandOP Surgical Lights Due to Handle Detachment Risk
FDA (Devices) · 2018-04-18
- HighMaquet Surgical Light Suspension Arms Recalled for Debris Risk
FDA (Devices) · 2015-07-15
- HighMaquet Volista OR Light Systems Recalled for Fall Hazard
FDA (Devices) · 2024-01-24