BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled Nationwide
Beaver Visitec International is recalling BVI CustomEyes Procedure Packs containing Sol-Millennium Medical syringes due to a voluntary recall initiated by the syringe manufacturer. 76 units affected 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 recall with no reported illnesses, injuries, or hospitalizations. The recall is voluntary and precautionary in nature, with no specific hazard detailed in the source material. Per the rubric, voluntary precautionary recalls without reported incidents are classified as Moderate.
Plain-English summary
Beaver Visitec International, Inc. is recalling BVI CustomEyes Procedure Packs (Part Number 58002042) that contain Sol-M Luer Lock and Luer Slip 1ml syringes manufactured by Sol-Millennium Medical, Inc.
The recall is in response to a voluntary recall of the Sol-M syringes by their manufacturer. Specific details regarding the defect or reason for the recall have not been disclosed in the recall notice.
Approximately 76 units of the affected procedure packs were distributed nationwide in the United States. The affected product has UDI-DI 30886158034309 and Lot Number 6073501.
If you have BVI CustomEyes Procedure Packs with part number 58002042, contact Beaver Visitec International, Inc. or your distributor for instructions regarding return or replacement of the affected units.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002042;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- Affected units
- 76
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: 58002042
- UDI-DI: 30886158034309
- Lot/Batch Number: 6073501
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.
See all →- ModerateLaser and endoscopy systems recalled over ferrites omitted from a USB cable
FDA (Devices) · 2026-01-07
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Issue
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
Same hazard · device defect
See all →- SevereBard Access Systems Recalls Power-Trialysis Dialysis Catheters
FDA (Devices) · 2026-09-23
- SevereBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
Similar recalls
- HighCustomEyes kits recalled due to potential sterility compromise
FDA (Devices) · 2023-03-08
- HighBeaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility
FDA (Devices) · 2015-06-24
- HighBeaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves
FDA (Devices) · 2015-06-24
- HighBeaver-Visitec Recalls Ophthalmic Kits with Defective Devon Light Gloves
FDA (Devices) · 2015-06-24
- HighBeaver-Visitec Recalls Ophthalmic Kits with Defective Sterile Gloves
FDA (Devices) · 2015-06-24
- ModerateBVI Visitec Irrigation Handle lacks manufacturing and expiration dates
FDA (Devices) · 2024-03-20