Waltham, MA, United States
Beaver Visitec International, Inc. recalls
12 recalls recorded since 2018, most recently on 26 July 2024. 12 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)12
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 26 July 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2844-2024, Z-2909-2024, Z-2890-2024, Z-2937-2024, Z-2931-2024, Z-2781-2024, Z-2896-2024, Z-2888-2024, Z-2877-2024, Z-2928-2024, Z-2875-2024, Z-2843-2024 and 147 more
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001737;
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001609;
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002075;
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001973;
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584003;
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001635;
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001605;
- and 151 more product lines
Ongoing Class II Medical devices
- Recall started
- 10 May 2024
- Reason
- 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).
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, UK, and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2161-2024, Z-2162-2024
- Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
- Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227, a component of CustomEye Kits, Numbers 584562, 5800109
Ongoing Class II Medical devices
- Recall started
- 2 February 2024
- Reason
- Pack and pouch label is missing the manufacturing and expiration date.
- Distribution
- Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1294-2024
- BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
Ongoing Class II Medical devices
- Recall started
- 10 October 2023
- Reason
- 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.
- Distribution
- International Distribution to Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0633-2024
- Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Ongoing Class II Medical devices
- Recall started
- 25 August 2023
- Reason
- One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.
- Distribution
- International distribution to the countries of Belgium, China, France, Germany, Greece, Italy, Jordan, Lithuania, Netherlands, Oman, Poland, Spain, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0632-2024
- Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
Ongoing Class II Medical devices
- Recall started
- 17 March 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1497-2023
- CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It creates a tip at cryogenic temperatures by evaporation of N2O that can be utilized to perform cryotherapy based on the destruction of tissue
Ongoing Class II Medical devices
- Recall started
- 20 December 2022
- Reason
- Device packaging may contain open seals, compromising product sterility.
- Distribution
- US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1199-2023, Z-1200-2023
- Ultracell Wick with 80cc Collection Bag, 20/box
- CustomEyes kits
Ongoing Class II Medical devices
- Recall started
- 30 November 2022
- Reason
- Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0782-2023
- Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Ongoing Class II Medical devices
- Recall started
- 30 September 2022
- Reason
- 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
- Distribution
- FL, GA, IN, LA, MA, ME, VA Foreign: France, Japan, Netherlands, Switzerland, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0197-2023
- Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780
Ongoing Class II Medical devices
- Recall started
- 26 April 2022
- Reason
- 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
- Distribution
- US Nationwide distribution in the states of AZ, CA, CT, DC, FL, GA, IN, MA, MN, NV, SC, TX, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1281-2022
- BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251
Ongoing Class II Medical devices
- Recall started
- 17 November 2021
- Reason
- Kit packaging may have small holes compromising product sterility
- Distribution
- CA, CO, LA, MA, MD, ND, PA, TN, UT
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0409-2022, Z-0410-2022, Z-0405-2022, Z-0407-2022, Z-0408-2022, Z-0406-2022
- Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
- Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
- Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
- Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
- Malosa Core Phaco Pack 2- Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK834/1
- Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
Ongoing Class II Medical devices
- Recall started
- 8 October 2021
- Reason
- Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
- Distribution
- Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0229-2022, Z-0227-2022, Z-0230-2022, Z-0228-2022
- bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
- Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
- bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
- bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.