BVI CustomEyes Procedure Packs recalled due to Sol-M syringes
BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled due to a voluntary manufacturer recall of the syringe components included in these procedure packs.
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 precautionary recall initiated by the syringe manufacturer with no reported illnesses or injuries mentioned in the source. While classified as FDA Class II, the absence of reported incidents and the manufacturer-initiated precautionary action result in a Moderate severity score.
Plain-English summary
BVI CustomEyes Procedure Packs have been recalled due to a voluntary manufacturer recall of syringes made by Sol-Millennium Medical (Sol-M), Inc. The affected packs contain Sol-M low dead space syringes and luer slip tip syringes, identified by part number 58001568.
Approximately 45 units of the affected procedure packs were distributed to medical facilities and suppliers throughout the United States. The recalled syringe lot numbers are 6059666 and 6073550. This recall was initiated voluntarily by the syringe manufacturer as a precautionary measure.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568;
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 45
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: 58001568
- UDI-DI: 30886158024683
- Lot/Batch Number: 6059666
- 6073550
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 · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- HighSyringes with Luer Slip Tips Recalled for Unapproved Design Modifications
FDA (Devices) · 2024-09-18
- HighSyringes with Needles Recalled for Substantial Design Differences from FDA Approval
FDA (Devices) · 2024-09-18
- HighMultiple Syringe Models Recalled for Deviation from FDA Clearance Specifications
FDA (Devices) · 2024-09-18
- HighROi CPS Recalls Custom Procedure Kits Containing Recalled BD Syringes
FDA (Devices) · 2020-06-17
- HighSOL-CARE and SOL-M syringes recalled for unapproved design modifications
FDA (Devices) · 2024-09-18
- HighB.Braun NORM-JECT Luer Lock Solo 10ml Syringe Sterility Recall
FDA (Devices) · 2023-10-04