Official recall record
DuraSeal Dural Sealant
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-03-26
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Through an internal investigation, it was determined that there is no age restriction statement on the Canadian IFU for the DuraSeal Dural Sealant system. Upon review of the IFU and supporting evidence, it was determined that the following age restriction should be included in the IFU: "Precaution: do not use in patients younger than 13 years of age." Recall Start Date: March 13, 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.
Record last checked against the registry on 2026-05-31.
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