FDA Recalls BVI CustomEyes Procedure Packs Containing Sol-M Syringes
Beaver Visitec International has voluntarily recalled BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. The affected procedure packs were distributed nationwide in the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device recall with no reported illnesses, injuries, or deaths. The recall is voluntary and precautionary in nature without specific disclosed hazard details, meeting the criteria for Moderate severity.
Plain-English summary
Beaver Visitec International, Inc. has issued a voluntary recall of BVI CustomEyes Procedure Packs that contain syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The recalled syringes are low dead space and luer slip tip 1ml syringes.
These affected procedure packs were distributed nationwide throughout the United States. The specific reason for the voluntary recall is not disclosed in the FDA recall notice.
Healthcare providers and facilities that have received these procedure packs should contact Beaver Visitec International or the FDA for information and instructions regarding the recalled product. They should not use the affected procedure packs until further guidance is provided.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000985;
- Manufacturer
- Beaver Visitec International, Inc.
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 (3)
- Part Number: 58000985
- UDI-DI: 30886158021460
- Lot/Batch Number: 6072192
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03