Health Canada Issues Type I Recall of Dräger VentStar Neo Resuscitation Devices

Health Canada has classified a recall of two neonatal ventilation accessories made by German manufacturer Draegerwerk AG & Co. KGaA as a Type I recall, the agency’s highest-risk category, after reports that hoses on the devices can develop visible cracks before they are ever used on a patient.

The recall covers the Dräger ‘VentStar Resus Neo’ (model MP00310) and the ‘VentStar Resuscitaire’ (model MP00311), both of which are single-use breathing circuit components used in neonatal and infant resuscitation and ventilation setups in hospitals. The recall was dated August 24, 2026, and published by Health Canada on August 25, 2026, under identification number RA-82525.

Products Affected by This Recall

Two Dräger products are named in the notice, and Health Canada says the recall applies to all lots of both items currently in circulation:

• VentStar Resus Neo — model or catalogue number MP00310, all lots affected
• VentStar Resuscitaire — model or catalogue number MP00311, all lots affected

Because the recall spans every lot rather than a specific batch, any hospital or clinical unit stocking either item should treat its full inventory as within scope.

What Went Wrong?

According to Health Canada’s notice, Draegerwerk became aware of instances in which users detected obvious cracks in the hose of the affected devices prior to use, meaning the defect was visible on inspection before the product was connected to a patient. The company reports that it has not received any reports linking the cracked hoses to negative health effects in patients.

Still, the agency’s notice is careful to flag that this cannot be fully ruled out if a crack were to go undetected during a pre-use check, since a compromised hose in a resuscitation or ventilation circuit could affect the delivery of air or oxygen to a vulnerable neonatal patient at a critical moment.

Who Should Be Concerned

The affected products are healthcare devices, not items sold directly to consumers, so the recall’s intended audience is hospitals, neonatal and pediatric care units, anaesthesiology departments, and other healthcare facilities that may have the VentStar Resus Neo or VentStar Resuscitaire in their supply of ventilation and resuscitation equipment. The listing categorizes the issue under ‘Health products – Medical devices – Anaesthesiology.’

Health Canada’s summary lists the intended audience simply as ‘Healthcare,’ underscoring that this is a clinical-setting recall rather than a home-use consumer alert.

What Should You Do?

Health Canada’s guidance is direct: facilities or clinicians with the affected devices should contact the manufacturer if they require additional information. The notice does not detail a specific return or refund process in the published summary, so healthcare providers holding stock of either device are advised to reach out to Draegerwerk AG & Co. KGaA directly, and in the meantime to visually inspect hoses for cracking before use, consistent with the defect described in the recall.

Facilities can also consult Health Canada’s recall database for updates, and any healthcare provider who suspects a related device issue is encouraged to report it through Canada’s official health and safety concern reporting channel.

From the Agency

Health Canada’s published notice states plainly that ‘the manufacturer has became aware of cases in which obvious cracks in the hose of the VentStar Resus Neo and VentStar Resuscitaire were detected by the users prior to use,’ adding that in no case was Draeger informed of negative health effects, though the possibility ‘cannot be completely ruled out if such crack remains undetected.’

The recall is listed as originating from Draegerwerk AG & Co. KGaA, headquartered at Moislinger Allee 53-55, Lubeck, Germany, and was published by Health Canada with a Type I classification, its designation for situations with the greatest potential for serious health consequences.