Beaver Surgical Eye Knife Recalled for Sterile Barrier Compromise
Beaver Visitec is recalling its surgical eye knife (Part 376630) used in cataract procedures due to compromised sterile packaging that may lead to infection. Approximately 599 units have been affected in the US.
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: FDA Class II recall for compromised sterile packaging on a surgical device used in eye procedures. The hazard presents a risk of infection, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury receive a score of 3.
Plain-English summary
Beaver Visitec International, Inc. is recalling the Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G), Part Number 376630. This surgical instrument is used for ocular paracentesis incisions during cataract procedures. The recall affects 599 units distributed nationwide in the US, consisting of 410 individual units and 189 kits. The affected lot number is 3391035. Some units were packaged as components of the READYPAK KIT (Cat. 584896, Lots 6054175 and 6053035).
The device is being recalled due to a compromised packaging sterile barrier. Open seals can result in a loss of device sterility and may lead to infection.
This recall affects healthcare facilities and surgical centers throughout the US. Providers and facilities should verify their inventory using the provided lot numbers. Patients who have undergone cataract procedures and are concerned about potential exposure should contact their healthcare provider.
The recalled product
- Product
- Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
- Manufacturer
- Beaver Visitec International, Inc.
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)
- 6053035
Distribution
Distributed nationwide across the United States.
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 loss
See all →- SevereChloraPrep One-Step Topical Solution Sterility Assurance Recall
FDA (Drugs) · 2026-07-01
- SevereNicardipine Hydrochloride Injection Recalled for Potential Sterility Loss
FDA (Drugs) · 2025-05-07
- HighSterile surgical drapes recalled due to potential packaging breach
FDA (Devices) · 2025-03-26
- HighMedline Proxima Sterile Surgical Drapes Recalled for Packaging Breach Risk
FDA (Devices) · 2025-03-26
- HighSurgical drapes recalled due to potential sterility breach in packaging
FDA (Devices) · 2025-03-26
Similar recalls
- HighBeaver-Visitec Recalls Safety Knives Due to Retracted Protective Shield
FDA (Devices) · 2018-02-07
- HighBeaver Xstar Crescent Knife surgical blades recalled for specification mismatch
FDA (Devices) · 2021-11-24
- HighCataract Surgery Kits Recalled for Compromised Sterile Packaging
FDA (Devices) · 2021-12-29
- HighBeaver Safety Sideport Knife Recalled Due to Retracted Protective Shield
FDA (Devices) · 2018-02-07
- HighBeaver Optimum Safety Sideport Knife Recalled Due to Retracted Shield
FDA (Devices) · 2018-02-07
- HighBeaver Visitec Safety Sideport Knife Blades May Detach During Surgery
FDA (Devices) · 2018-07-11