Beaver-Visitec International, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1211998
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 195181 ongoing
What Beaver-Visitec International, Inc. makes
The company manufactures single-use ophthalmic surgical tools and accessories, including non-medicated procedure kits, irrigation/infusion/aspiration cannulas, soft-tissue manipulation forceps, ocular hooks, spatulas, lacrimal punctum plugs, and surgical drapes. It also produces human-derived ENT space-occupying dressings and custom ophthalmic sponges for surgical use.
These devices are classified under FDA’s Class I and Class II categories, with some falling under the exempt (U) classification. They are listed in the FDA’s Unique Device Identifier (UDI) database, adhering to U.S. regulatory requirements.
Company details
- FDA FEI number
- 1211998
- Address
- 303 Wyman St Ste 350, Waltham, MA, 02451
FDA recalls
Recalls initiated per year
- 2017 5
- 2018 2
- 2019 0
- 2020 0
- 2021 10
- 2022 5
- 2023 3
- 2024 162
- 2025 1
- 2026 0
2025
- 5 Dec 2025 Z-1008-2026 Class II Ongoing 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 specifications, which require two ferrites (one at each end of the cable).
2024
- 26 Jul 2024 Z-2781-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2782-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2783-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2784-2024 Class II Ongoing Data in RES.
- 26 Jul 2024 Z-2785-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2786-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2787-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2788-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2789-2024 Class II Ongoing 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.
Show the 25 most recent of 195 recalls
2024
- 26 Jul 2024 Z-2790-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2791-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2792-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2793-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2794-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2795-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2796-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2797-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2798-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2799-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2800-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2801-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2802-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2803-2024 Class II Ongoing 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.
- 26 Jul 2024 Z-2804-2024 Class II Ongoing 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.
FDA establishments
- Beaver-Visitec International, Inc. Ciudad Juarez Chihuahua · MX FEI 3013421458
- Beaver-Visitec International, Ltd BIDFORD-ON-AVON Warwickshire · GB FEI 3002808441