Official recall record
Cardinal Health Level 3 Isolation Gowns
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-11-20
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
The listed product codes and all lots of Cardinal Health Level 3 Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (the Association for the Advancement of Medical Instrumentation) level 3 protection requirements. The raw material identified has demonstrated possible degradation due to exposure to lighting, temperature, and relative humidity beyond the manufacturer recommended limits. This product recall is specific to the codes listed. Other codes are not impacted. Recall Start Date: November 5, 2024
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.
Record last checked against the registry on 2026-05-31.