Quality & complianceOfficial

Health Canada lists Type II recall of Beaver-Visitec Mini Blades over seal integrity concern

🇨🇦 Health Canada · Thu 12 Nov 2026

Beaver-Visitec International has recalled certain Mini Blades units after finding an intermittent "open seal" condition that means sterility cannot be guaranteed, Health Canada reports.

Health Canada has published a Type II recall of Beaver-Visitec International (BVI) Mini Blades, citing a potential seal integrity problem in certain units. The notice, identified as RA-82949, was posted on 12 November 2026. The recall date is given as 2 November 2026.

According to the notice, the flaw may produce an "open seal" condition, in which the sterility of the product cannot be guaranteed. BVI says the condition was confirmed through physical investigation, including visual inspection and dye penetration testing.

Investigation and sampling to date indicate that the problem is intermittent and does not affect every unit in the affected lots. The notice does not say how many units are involved, and it does not report any injuries or adverse events.

Six model or catalogue numbers are listed: 364823, BEAVER6900, BEAVER6700, BEAVER6400, 364820 and 364822. Each is associated with more than 20 lot numbers, which the notice does not itemise. Healthcare audiences are told to contact the manufacturer for further information. The notice sits in the general and plastic surgery category of medical devices.

As general context, a Type II recall in Canada covers products that may cause temporary or medically reversible health effects, or where the likelihood of serious harm is remote.

What it means for your team

  • Facilities holding Mini Blades under the six listed catalogue numbers should contact BVI for the full lot list, as the Health Canada notice does not reproduce it.
  • Quality teams may wish to check sterile-barrier and seal-integrity controls and stock segregation against the manufacturer's instructions once received.
  • Regulatory teams with a presence outside Canada should check whether the same catalogue numbers are distributed in their markets, since this notice covers only the Canadian recall.
  • The failure is intermittent and not present in every unit of an affected lot, so lot-level checks alone may not settle whether a given unit is compromised.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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