Official recall record
Level 1® Fast Flow Fluid Warmer and Level 1® NORMOFLO Irrigation Fluid Warmer
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-07-19
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Smiths Medical is issuing this letter to notify customers of a potential issue related to the Level 1 Fast Flow Fluid Warmers and Level 1 NORMOFLO Irrigation Fluid Warmers: 1. The return tube assembly inside the warmers may exhibit stress cracking that can propagate over time and potentially result in leaking recirculating fluid. Leaking recirculating fluid may potentially damage other components within the warmer, such as the printed circuit board. 2. The cable inside the warmers that connects to the external on/off switch may potentially exhibit delamination of insulation which may propagate over time and may lead to corrosion and a break in the electrical circuit. Recall Start Date: July 2, 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.