BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Component
Beaver Visitec International recalled BVI CustomEyes Procedure Packs containing defective 1ml syringes manufactured by Sol-Millennium Medical. The 68-unit recall involves procedure packs 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: The recall is FDA Class II but involves a voluntary precautionary action with no reported illnesses, injuries, or deaths. The rubric explicitly assigns voluntary precautionary recalls to the Moderate category when no serious harm is documented.
Plain-English summary
Beaver Visitec International, Inc. issued a voluntary recall of BVI CustomEyes Procedure Packs containing 1ml syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. The affected procedure packs contain low dead space syringes with luer slip tip connectors. The recall involves 68 units (Part Number 58000709, Lot/Batch Number: 6069363, UDI-DI: 30886158019955).
The affected procedure packs were distributed nationwide throughout the United States. While the recall notice does not specify the reason for the recall or recommended consumer actions, affected facilities and users should seek additional information from Beaver Visitec International or the U.S. Food and Drug Administration regarding return or disposal procedures.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000709;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- device-defect
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: 58000709
- UDI-DI: 30886158019955
- Lot/Batch Number: 6069363
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