RegWardenFDA facility compliance records
Facility

Beaver-Visitec International, Inc

24 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls; 2015: 1 recalls; 2017: 1 recalls; 2018: 6 recalls; 2019: 2 recalls; 2020: 1 inspections; 2021: 2 recalls; 2022: 4 recalls; 2023: 3 recalls; 2024: 3 recalls; 2025: 1 recalls1’141’15’161’176’182’191’202’214’223’233’241’25’26
  • Recalls (24)
  • Inspections (1)

Devices registered here (2)

Recalls & enforcement

20251 record
  • Class IIOngoing2025-12-05
    Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design s…
20243 records
  • Class IIOngoing2024-07-26
    Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes manufactured by Sol-M are present in some of BVI CustomEyes Procedure Packs.
  • Class IIOngoing2024-05-10
    The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
  • Class IIOngoing2024-02-02
    Pack and pouch label is missing the manufacturing and expiration date.
20233 records
  • Class IIOngoing2023-10-10
    One lot of Part Number 373025, Xstar® Kojo Safety Slit Knife 2.5mm 45® bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
  • Class IIOngoing2023-08-25
    One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.
  • Class IIOngoing2023-03-17
    Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device suddenly or forcefully disassembles during a cryosurgery procedure.
20224 records
  • Class IIOngoing2022-12-20
    Device packaging may contain open seals, compromising product sterility.
  • Class IIOngoing2022-11-30
    Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
  • Class IIOngoing2022-09-30
    Incorrect configuration of the blades in the package. The blades curve to the right instead of curving to the left. If used may cause cause unintended tissue damage during the procedure or if noticed prior to use may cause a delay in surgery
  • Class IIOngoing2022-04-26
    Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250
20212 records
20192 records
  • Class IITerminated2019-03-12
    Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
  • Class IIITerminated2019-02-19
    The product contains a misprinted expiration date on the peel pack. Both were printed as "180615", which is the lot number. The Lot number is correct.
20186 records
  • Class IITerminated2018-11-30
    Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigat…
  • Class IITerminated2018-07-19
    A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient.
  • Class IITerminated2018-06-18
    Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
  • Class IITerminated2018-05-14
    Blades are loose in handles and may fall out due to non cured epoxy
  • Class IITerminated2018-02-26
    Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
  • Class IITerminated2018-02-26
    Products were packaged with incorrect labeling,
20171 record
20151 record
20141 record

FDA inspections (1)

  • NAI2020-03-05
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Beaver-Visitec International, Inc (FEI 1000122089) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000122089-beaver-visitec-international-inc/

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