Beaver-Visitec International, Inc.

• Wet-Field® Eraser® 221260 Ref 221260

  Class II EUDAMEDFDA UDI Active

• Plus A14-205BN Ref A14-205BN

  Unclassified FDA UDI Active

• Keracel 400122B Ref 400122B

  Class II FDA UDI Active

• Readypak Kit 584902 Ref 584902

  Class I FDA UDI Active

• Extend™ A13-204 Ref A13-204

  Unclassified FDA UDI Active

• Readypak 584934 Ref 584934

  Class I FDA UDI Active

• Merocel 705103 Ref 705103

  Class II FDA UDI Active

• Plus A14-205 Ref A14-205

  Unclassified FDA UDI Active

• Micro Flow™ A20-403BN Ref A20-403BN

  Unclassified EUDAMEDFDA UDI Active

• Endo Optiks® OME230LA Ref OME230LA

  Class II FDA UDI Active

• Mini-Blade® BEAVER6700 Ref BEAVER6700

  Class I EUDAMEDFDA UDI Active

• Malosa Medical MMSU1440S Ref MMSU1440S

  Class I FDA UDI Active

• Malosa Medical MMSU1428S Ref MMSU1428S

  Class I FDA UDI Active

• Malosa Medical MMSU1260S Ref MMSU1260S

  Class I FDA UDI Active

• Readypak 58000130 Ref 58000130

  Class I FDA UDI Active

• Accu-Temp® 8446000 Ref 8446000

  Class II EUDAMEDFDA UDI Active

• Malosa Medical MMSU1124S Ref MMSU1124S

  Class I FDA UDI Active

• Ultracell® NS90950 Ref NS90950

  Class I FDA UDI Active

• Readypak Kit 584191 Ref 584191

  Class I FDA UDI Active

• Keracel 705102 Ref 705102

  Class II FDA UDI Active

• Endo Optiks® OME200SMAHRXVA Ref OME200SMAHRXVA

  Class II FDA UDI Active

• Merocel 223622NS Ref 223622NS

  Class II FDA UDI Active

• Keracel 453101 Ref 453101

  Class II FDA UDI Active

• Readypak Kit 583805 Ref 583805

  Class I FDA UDI Active

• Readypak Kit 583816 Ref 583816

  Class I FDA UDI Active

• Readypak Kit 584808 Ref 584808

  Class I FDA UDI Active

• Readypak Kit 583950 Ref 583950

  Class I FDA UDI Active

• Malosa Medical MMSU1458S Ref MMSU1458S

  Class I FDA UDI Active

• Merocel 405101 Ref 405101

  Class II FDA UDI Active

• Ultracell® 20212-C Ref 20212-C

  Class I FDA UDI Active

• Ultracell 40431 Ref 40431

  Class II EUDAMEDFDA UDI Active

• Merocel 400117 Ref 400117

  Class II FDA UDI Active

• Endo Optiks® OME230SMAXA Ref OME230SMAXA

  Class II FDA UDI Active

• Readypak Kit 583954 Ref 583954

  Class I FDA UDI Active

• Malosa Medical MMSU1253S Ref MMSU1253S

  Class I FDA UDI Active

• Accu-Temp® 8461050 Ref 8461050

  Class II FDA UDI Active

• Readypak Kit 584860 Ref 584860

  Class I FDA UDI Active

• Readypak Kit 584931 Ref 584931

  Class I FDA UDI Active

• Endo Optiks® OME200SMAHRVA Ref OME200SMAHRVA

  Class II FDA UDI Active

• Visitec® EdgeAhead® 581127 Ref 581127

  Class I FDA UDI Active

• Readypak 583928 Ref 583928

  Class I FDA UDI Active

• Readypak Kit 584867 Ref 584867

  Class I FDA UDI Active

• Ophthalmic Blade Handles, Collets & Wrenches Ref 374320

  Class I EUDAMEDFDA UDI Active

• Ophthalmic Blade Handles, Collets & Wrenches Ref 371305

  Class I EUDAMEDFDA UDI Active

• Leos Laser and Endoscopy System Ref K240615

  Class II FDA 510(k) Active

• Ophthalmic Blade Handles, Collets & Wrenches Ref 371410

  Class I EUDAMEDFDA UDI Active

• Ophthalmic Blade Handles, Collets & Wrenches Ref 371395

  Class I EUDAMEDFDA UDI Active

• Ophthalmic Blade Handles, Collets & Wrenches Ref 371394

  Class I EUDAMEDFDA UDI Active

• Ophthalmic Blade Handles, Collets & Wrenches Ref 374310

  Class I EUDAMEDFDA UDI Active

• Ophthalmic Blade Handles, Collets & Wrenches Ref 371350

  Class I EUDAMEDFDA UDI Active

Showing the 10 most recent of 195 recalls.

• 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).via FDA establishment Beaver-Visitec International, Inc.

• 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.via FDA establishment Beaver-Visitec International, Inc.
  • 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.via FDA establishment Beaver-Visitec International, Inc.
  • 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.via FDA establishment Beaver-Visitec International, Inc.
  • 26 Jul 2024 Z-2784-2024 Class II Ongoing Data in RES.via FDA establishment Beaver-Visitec International, Inc.
  • 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.via FDA establishment Beaver-Visitec International, Inc.
  • 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.via FDA establishment Beaver-Visitec International, Inc.
  • 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.via FDA establishment Beaver-Visitec International, Inc.
  • 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.via FDA establishment Beaver-Visitec International, Inc.
  • 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.via FDA establishment Beaver-Visitec International, Inc.

• Beaver-Visitec International, Inc. Ciudad Juarez Chihuahua · MX FEI 3013421458
• Beaver-Visitec International, Ltd BIDFORD-ON-AVON Warwickshire · GB FEI 3002808441

Address

6447 Parkland Drive, Sarasota, United States

Website

BVIMedical.com

Email

[email protected]

PRRC contact

Chris Brady

EUDAMED SRN

US-MF-000011461

FDA FEI number

1211998