Merit Medical Systems Recalls Cytosol Ophthalmics Balanced Salt Solution Kits
Merit Medical Systems is recalling Cytosol Ophthalmics Balanced Salt Solution kits due to a lack of assurance of sterility and potential endotoxin contamination.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling 2,470 Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile. The recall affects all convenience kits containing Part Number 8118, across all lot numbers.
The recall was initiated due to a lack of assurance of sterility. The procedure kits contain a balanced salt solution that may be contaminated with endotoxins. The affected products were distributed in Connecticut, Maryland, Ohio, and South Carolina.
Consumers and healthcare providers should stop using the affected kits and contact Merit Medical Systems for further instructions or a replacement.
The recalled product
- Product
- Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
- Manufacturer
- Merit Medical Systems, Inc
- Affected units
- 2,470
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)
- All convenience kits containing Part Number 8118
- all lot numbers.
Distribution
Related recalls
Same manufacturer · Merit Medical Systems, Inc
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Same hazard · endotoxin contamination
See all →- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- HighNeurological Sponges Recalled Due to Potential Variability in Endotoxin Levels
FDA (Devices) · 2026-08-05
- HighMedline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin
FDA (Devices) · 2026-05-06
Similar recalls
- HighMerit Medical convenience kits recalled for syringe leaks and breakage
FDA (Devices) · 2024-08-21
- HighMerit Medical Procedure Kits Recalled for Compromised Sterile Barrier
FDA (Devices) · 2016-11-30
- HighMerit Medical Convenience Kits Recalled for Defective Plastic Syringes
FDA (Devices) · 2024-08-21
- HighMerit Medical Convenience Kits With Recalled Syringes Pose Quality Defect Risks
FDA (Devices) · 2024-08-21
- HighFDA Recalls Merit Pursue Microcatheter Due to Sterility Concerns
FDA (Devices) · 2024-01-10
- SevereMerit Medical Systems Recalls Non-Sterile Custom Syringe Kits
FDA (Devices) · 2014-04-09