ProductGuru Recalls

Official recall record

Tandem INTL Bipolar 46OD 28ID

Health Canada — Medical Devices · 2024-10-30 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-10-30
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Smith & Nephew, Inc., has initiated a field action to voluntarily remove a batch of Tandem Bipolar 46OD 28ID due to the assembly of an oversized retainer ring in the product. This results in a reduced retention force of the bipolar assembly. Recall Start Date: October 15, 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.

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

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