Health Canada Recalls Cardinal Health Gynaecology, Endoscopy Packs 2026

Health Canada has published a Type II medical device recall covering Cardinal Health Gynaecology Robotics and Endoscopy Packs, after the packs’ handpiece component was linked to a growing number of leak complaints during surgical use. The recall, identified under number RA-82533, was dated August 19, 2026 and formally listed by Health Canada on August 27, 2026.

The recall originates further up the supply chain. According to the notice, Cardinal Health was informed by device maker Stryker of a recall concerning the ‘StrykeFlow PS’ component referenced within these surgical packs. Stryker’s own recall was prompted by an increase in reported complaints, with users consistently describing leaking from the handpiece while it was in use during procedures.

What Products Are Being Recalled?

The recall affects two categories of Cardinal Health surgical packs distributed for hospital and clinical use:

• ‘Gynaecology Robotics Packs’ — Lot number 777190, model/catalogue number SMA30RBHSA
• ‘Endoscopy Packs’ — Lot number 739814, model/catalogue number SBA30EDCLB
• ‘Endoscopy Packs’ — Lot number 694042, model/catalogue number SBA30EDCLB

These packs are sold under the brand ‘Cardinal Health 200, LLC, Also Trading As Cardinal Health,’ a company based at 3651 Birchwood Drive, Waukegan, Illinois. The affected packs are categorized by Health Canada under general hospital and personal use, as well as general and plastic surgery devices.

What Triggered the Recall

The core issue is a hardware performance defect rather than contamination or labeling error. Healthcare facilities and clinicians reported that the handpiece associated with the StrykeFlow PS system was leaking fluid during active use. Because these packs are used in gynaecological robotic procedures and endoscopy — both of which rely on precise fluid management and sterile conditions during surgery — a leaking handpiece raises concerns about procedural interruption, contamination of the surgical field, and reduced device reliability mid-operation.

Health Canada has classified this as a Type II recall, a category generally reserved for situations where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is considered remote. The recall was published under the medical device performance issue category.

Who Should Be Concerned

This recall is directed at a healthcare audience rather than the general public. Hospitals, surgical centers, and clinical staff who use Cardinal Health’s Gynaecology Robotics Packs or Endoscopy Packs — particularly those matching the specific lot and model numbers listed above — are the intended recipients of this alert. Because these are professional surgical products supplied directly to healthcare facilities, individual consumers would not typically purchase or handle them directly.

Facilities should check current inventory and any packs already staged for upcoming procedures against the lot numbers 777190, 739814, and 694042, along with model numbers SMA30RBHSA and SBA30EDCLB, to determine whether they hold affected stock.

Steps Consumers Should Take

Health Canada’s guidance for this recall is straightforward: affected facilities and staff should contact the manufacturer directly if they require additional information about the packs in their possession. Cardinal Health, as the distributing company named in the recall, is the appropriate point of contact for facilities seeking to confirm affected inventory, arrange returns, or ask about replacement components.

Institutions that identify matching lot or model numbers in their supply are advised to set the affected packs aside and avoid use until they have confirmed next steps with the manufacturer, given the reported handpiece leak issue during active procedures.

Regulatory Response

Health Canada’s published notice states plainly that ‘Cardinal Health was recently informed of a medical device recall from Stryker concerning the StrykeFlow PS referenced,’ and that the action followed ‘an increased amount in reported complaints consistently describing leaking from the handpiece during use.’ The recall falls under Health Canada’s medical devices recall and safety alert program, with the department listing the action’s audience strictly as ‘Healthcare.’

Health Canada continues to monitor medical device performance issues through its recalls and safety alerts database, and encourages healthcare providers to report any additional device performance concerns through its standard reporting channels.