BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes are being voluntarily recalled. The recall affects 840 units distributed nationwide.
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 2/5 (Moderate).
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 a voluntary recall of FDA Class II medical devices with no reported illnesses or injuries, consistent with precautionary recalls rather than response to documented harm.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-Millennium Medical (Sol-M) low dead space and luer slip tip 1ml syringes (Part Number 58000757) are subject to a voluntary recall.
A total of 840 units with lot/batch numbers 6069002 and 6071184 have been distributed nationwide in the United States. The procedure packs are manufactured and distributed by Beaver Visitec International, Inc.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000757;
- Manufacturer
- Beaver Visitec International, Inc.
- Affected units
- 840
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 (4)
- Part Number: 58000757
- UDI-DI: 30886158020265
- Lot/Batch Number: 6069002
- 6071184
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 159 recalled by Beaver Visitec International, Inc. 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 159 products in this recall →Related recalls
Same manufacturer · Beaver Visitec International, Inc.
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FDA (Devices) · 2026-01-07
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FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Defect
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
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