Official recall record
Titan® Inflatable Penile Prosthesis
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-11-10
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Pump bulbs are manufactured using 2 molds. A component on one of the two molds shifted during production. This resulted in a gradual build of material on the mold, which gradually decreased wall thickness of the pump. This occurred over the course of several weeks, culminating in a period of time (17 September 2022 to 02 December 2022) where pump bulbs were manufactured below the wall thickness specification. Recall Start Date: October 30, 2023
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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