Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026

REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

DeRoyal Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703

Is this the product you have?

  • REF
    • 81-030415 Myocardial Probe Non-Pyrogenic
    • 400 Series
Lot codes and dates
  • DI00749756046077/Lot # 63426754
Amount recalled
7 cases, 140 units

Where it was sold

Why it was recalled

Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Nov 4, 1:05 AM UTC

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