Maquet Percutaneous Insertion Kit and Dilator Sets Recall
Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.
Health Canada has issued a recall for Maquet Percutaneous Insertion Kit and Dilator Sets due to potential failures in sterile barrier integrity.
What this Health Canada recall tells you, and what most readers miss
This notice was issued by Health Canada on August 26, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, medical-devices.
What Happened
The manufacturer identified failures in sterile barrier integrity verification testing during a retrospective review. The packaging may not consistently maintain sterile barrier integrity for products in the PIK line within shelf-life.
Which Products Are Affected
- Dilator Sets: PIK DILATOR SET L
- Percutaneous Insertion Kit: PIK 150
Affected products are manufactured by Maquet Cardiopulmonary GmbH, Kehler Strasse 31, Rastatt, Germany, 76437. No lot or serial numbers are specified.
What You Should Do
No specific consumer actions are detailed in the recall notice. Contact the company or healthcare provider regarding affected products.
Why This Matters
Potential compromise of sterile barrier integrity may affect product safety for medical use.
Source
Health Canada - Published 2026-08-26
Original source: Health Canada Official Notice ↗
Related Product & Food Recalls
All Product & Food Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (933 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 26, 2026.
Frequently Asked Questions
Common questions about this Health Canada recall.