The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2925-2024·Announced 2024-09-04

BVI CustomEyes Procedure Packs recalled due to incorrect syringes

Beaver Visitec International is recalling BVI CustomEyes Procedure Packs because they contain syringes manufactured by Sol-Millennium Medical instead of the intended product. The recall involves 57 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 Class II medical device voluntary recall with no reported illnesses or injuries. The issue is a product inclusion defect—incorrect syringes included in the packs—rather than a demonstrated safety hazard, making it a moderate-level precautionary recall.

Plain-English summary

Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58001933) because some packs contain syringes manufactured by Sol-Millennium Medical, Inc. instead of the intended product. The affected syringes are low dead space syringes and Luer slip tip syringes.

The recall involves approximately 57 units of affected Procedure Packs (Lot Number 6073549) that were distributed nationwide. The product can be identified by UDI-DI: 30886158033555. This is a voluntary recall.

The recalled product

Product
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001933;
Manufacturer
Beaver Visitec International, Inc.
Category
Medical Device — Surgical / Ophthalmic
Hazard
Affected units
57

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: 58001933
  • UDI-DI: 30886158033555
  • Lot/Batch Number: 6073549

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 →

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