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FDA · Medical devices ·

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

DeRoyal Industries Inc recalled REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series on September 30, 2026 because of myocardial temperature probes contain an incorrect needle. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 7 cases, 140 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
DeRoyal Industries Inc, Powell, TN
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Status
Ongoing
Recall number
Z-3256-2026
Source
U.S. Food and Drug Administration

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