Class II
Medical Device Recall: REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
DeRoyal Industries Inc · August 20, 2026
Reason for Recall
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Distribution
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
States Affected
NATIONWIDE
Quantity Affected
7 cases, 140 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3256-2026
Status: ongoing
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