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Health Canada flags Intersurgical Smoothbore breathing system recall over connectors that may detach from tubing

🇨🇦 Health Canada · Fri 06 Nov 2026

Intersurgical is recalling several lots of Smoothbore-based breathing systems in Canada after market reports of soft connectors coming off the tube, with insufficient bonding solvent identified.

Health Canada has published a Type II recall of Intersurgical Ltd.'s Smoothbore Breathing System, listing the issue as a medical device performance problem. The recall date is 28 October 2026 and the notice was published on 6 November 2026 under identification number RA-82926.

According to the notice, too little tetrahydrofuran (THF) solvent is used during manufacturing to bond the soft connectors to the Smoothbore tube. The company received reports from the market of connectors disconnecting from the tube. Its investigation and testing of internal stock then found that the amount of solvent was not enough to ensure a secure connection.

The affected products span several catalogue numbers and lots. These are the 22mm Smoothbore Adult Cough Assist Breathing System with Mask and Flo-Guard System (5001011, lot 32510470), Smoothbore Breathing Systems under catalogue numbers 5183000 and 5191000 (lots 32527207, 32517823, 32516907 and 32511321 for each), Bilevel Breathing Systems (5805044, lots 32517459, 32518657 and 32515237) and a CPAP Breathing System (5804000, lot 32511639).

The notice is addressed to healthcare audiences and says only that people who need more information should contact the manufacturer. Intersurgical's Canadian address is listed as Burlington, Ontario. The notice does not describe any injuries, specific corrective actions or the number of units involved. Under Health Canada's system, a Type II recall generally applies where use of a product may cause temporary or medically reversible adverse effects, or where the risk of serious harm is considered remote.

What it means for your team

  • Quality teams should check stock against the listed catalogue numbers and lot numbers, as the recall is lot-specific.
  • The stated root cause is an insufficient solvent quantity in the bonding step, which makes this a process-control and manufacturing-validation issue as well as a product performance one.
  • Complaint and vigilance teams should note that the problem was detected through market reports of connector disconnection, then confirmed by internal stock testing.
  • The notice gives no details of recall actions or quantities, so affected organisations will need to contact the manufacturer for further instructions.

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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