Baylis Medical Company Inc. medical devices recall in Canada: sterility risk
In plain language
This recall involves VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath, and VersaCross™ Transseptal Sheath medical devices sold in Canada. They are being recalled because a potential hole in the sterile barrier pouch may compromise sterility. Contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
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Affected products
Specific affected products are listed in the official notice.
Why this matters
Sterility risk
Do I have this product?
This recall applies to specific products. Details are listed in the official notice.
Frequently Asked Questions
Why was this product recalled?
Sterility risk
What should consumers do?
Contact the manufacturer if you require additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Sterility risk
When was this product recalled?
This product was recalled on June 19, 2025.
Is the Baylis Medical Company Inc. brand affected by this recall?
Yes, Baylis Medical Company Inc. products are affected by this recall. This recall involves VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath, and VersaCross™ Transseptal Sheath medical devices sold in Canada. They are being recalled because a potential hole in the sterile barrier pouch may compromise sterility. Contact the manufacturer for more information.