Tracoe Experc Tracheostomy Sets Recalled Over Sleeve Risk 2026: Health Canada

Health Canada has classified a recall of Tracoe Experc Percut Dilation Tracheostomy Sets as Type II, after the manufacturer reported a very low risk that a silicone sleeve could detach during tube placement. The alert was published on October 14, 2026 under identification number RA-82782, and it is directed at healthcare audiences rather than the general public.

The affected product is the Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter, made by Tracoe Medical GmbH of Nieder-Olm, Germany. The company is issuing a Field Safety Notice, and the recall date listed by Health Canada is September 24, 2026.

Quick Facts

• Product: Tracoe Experc Percut Dilation Tracheostomy Set W/Trachatraumatic Inserter
• Manufacturer: Tracoe Medical GmbH
• Recall class: Type II
• Recall number: RA-82782
• Issue: Medical devices – Performance
• Lots affected: 6 lot numbers across 3 model numbers

Products Affected by This Recall

Six lots are named in the Health Canada notice, covering three catalogue numbers. All are listed under the same product name.

• Model 461-08-P: lot 1100026287
• Model 424-08: lots 1100024157, 1100024241 and 1100030719
• Model 423-08: lots 1100022836 and 1100030666

The source does not state how many units were distributed in Canada or elsewhere. It also gives no product image.

What Triggered the Recall

According to the notice, the application carries a very low risk that the silicone sleeve may detach from the guiding catheter when the insertion system of the tracheostomy tube is removed. The problem therefore arises at a specific step of the procedure, when the insertion system is withdrawn after the tube has been placed.

Tracoe describes the incidence rate as very low. Even so, the manufacturer has chosen to notify users through a Field Safety Notice because of the possible consequences if the sleeve does come loose.

What Could Go Wrong

Two outcomes are described in the notice. In the first, the detached sleeve may remain in the cannula and block it. That would require an immediate cannula change.

In the second, the sleeve may slip into the trachea. If that happens, immediate removal by bronchoscopy would be necessary. Both situations involve an airway device, which is why clinicians are being alerted even though the stated likelihood is very low.

The source does not report any injuries or adverse events linked to the issue.

Who Should Be Concerned

The audience for this alert is healthcare. Hospitals, intensive care units, anaesthesia departments and other facilities that stock or use the listed Tracoe tracheostomy sets should check their inventory against the lot and model numbers above. Health Canada files the alert under Health products, Medical devices, Anaesthesiology.

Members of the public are not the intended audience for this notice. Patients who have questions about a tracheostomy procedure they have had or are scheduled to have should raise them with their treating clinicians.

What Healthcare Providers Should Do

The action listed by Health Canada is brief: contact the manufacturer if you require additional information. Facilities holding the affected lots can use the lot and catalogue numbers in the table above to identify the products in question.

• Compare stock against the six lot numbers and three model numbers listed.
• Read the manufacturer’s Field Safety Notice if it has been received.
• Contact Tracoe Medical GmbH for further information or instructions.

The source page does not list a phone number, email address, refund process or return instructions, so those details should be obtained from the manufacturer directly.

Regulatory Response

The alert was published by Health Canada’s medical devices program and is categorised as a health product recall. The Type II classification is the one the agency lists for this recall. The page was last updated on October 14, 2026, the same date as the original publication.

Health Canada also invites people to report a health or safety concern through its online reporting service, and offers email notifications for new and updated recalls and safety alerts through the recalls and safety alerts website.

The Bottom Line

The risk described is rare, but it concerns a device used in the airway. Facilities using the Tracoe Experc Percut Dilation Tracheostomy Set should verify their lot numbers and keep in contact with the manufacturer for updates.