Beaver-Visitec International, Inc.

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

Devices registered here (1)

• Balloon, Epistaxis
  Product code EMX · Class I · Ear, Nose, Throat · 21 CFR 874.4100

Recalls & enforcement

• 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
• 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.
• 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.
• 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
• Class IIOngoing2021-11-17
  Kit packaging may have small holes compromising product sterility
• Class IIOngoing2021-10-08
  Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
• 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.
• 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,
• Class IITerminated2017-11-03
  The protective shield was retracted, and the blade was exposed.
• Class IITerminated2015-05-01
  Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product
• Class IITerminated2014-05-06
  Contains a sharp tip needle when the product should contain a blunt tip cannula

Related

• All facilities operated by Beaver-Visitec International, Inc.
• Beaver-Visitec International, Inc. (MX)
• Malosa Medical Instruments (Changshu) Limited (CN)
• Grupo American Industries, S.A. de C.V (MX)
• Beaver-Visitec International, Ltd (GB)
• Rio Bravo International Inc (TX)

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →