ProductGuru Recalls

Official recall record

10Fore™ Hemostasis Valve

Health Canada — Medical Devices · 2025-07-30 · CanadaType I
Issuing authority
Health Canada — Medical Devices
Published
2025-07-30
Country of alert
Canada
Alert level
Type I
Alert type
recall

What the authority reported

Merit Medical became aware of a manufacturing quality concern during routine QA inspection of a 10Fore™ Hemostasis Valve work order in February 2025. Initial defect assessments determined the observed damage to the silicone quad ring was due to the manual nature of operator handling and subsequent placement/positioning of the quad ring into the corresponding y body. If the ring is not gently manipulated and/or not fully seated in its intended position during the pressing process it can become deformed or otherwise damaged. Recall start date: July 25, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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