Beaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves
Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Beaver-Visitec International Inc. is recalling 384 BVI Custom Eyes Ophthalmic Procedure Kits. The recall is due to a defect in the Devon Light Glove component (Part Number 584648), which may contain holes or slits that compromise the sterility of the product.
The affected kits were distributed nationwide, including in Kentucky, Georgia, Michigan, and New Jersey. The specific lot numbers involved are 3038787, 3046210, 3061080, 3078492, 3093681, 3095940, and 3108668.
Healthcare facilities and consumers should stop using these kits and contact the manufacturer for further instructions. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
- Manufacturer
- Beaver-Visitec International Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 384
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 (1)
- Lot Numbers: 3038787 3046210 3061080 3078492 3093681 3095940 3108668
Distribution
Part of a larger recall action
This product is one of 5 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 5 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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighFDA Recalls Devon Light Gloves for Sterility Compromising Defects
FDA (Devices) · 2015-07-29
- HighSurgical Kits Recalled Due to Glove Splits Compromising Sterility
FDA (Devices) · 2015-07-29
- HighMinor Surgical Kits Recalled Due to Sterility Compromise in Gloves
FDA (Devices) · 2015-07-29
- HighRecall of Sterile Major Kits with Defective Devon Light Gloves
FDA (Devices) · 2015-07-29
- HighFDA Recalls Sterile Devon Light Gloves Due to Splits and Holes
FDA (Devices) · 2015-07-29
- ModerateBVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Defect
FDA (Devices) · 2024-09-04