FDA Recalls BVI CustomEyes Procedure Packs with Sol-M Syringes
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary manufacturer recall. The affected packs have been distributed nationwide in the US.
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: This is an FDA Class II medical device recall with no reported illnesses, injuries, or detailed hazard information in the source. The recall is explicitly described as voluntary, fitting the criteria for Moderate severity per the FDA classification without evidence of patient harm.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58001845) that contain low dead space and Luer slip tip 1ml syringes manufactured by Sol-Millennium Medical, Inc. (Sol-M). This recall is being conducted because of a voluntary recall of these syringes by the manufacturer.
The affected procedure packs contain the specified Sol-M syringes. One lot has been identified: Lot Number 6069639, with UDI-DI 30886158033210.
Approximately 16 units of the affected BVI CustomEyes Procedure Packs have been distributed nationwide throughout the United States.
Clinicians and healthcare facilities who have received the recalled procedure packs should stop using them and contact Beaver Visitec International, Inc. for further instructions regarding the recalled products.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001845;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- syringe-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: 58001845
- UDI-DI: 30886158033210
- Lot/Batch Number: 6069639
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