DeRoyal Industries Inc — REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider: FDA — device enforcement reference
Source observed: 8/20/2026, 12:00:00 AM UTC
Source updated: 9/22/2026, 12:00:00 AM UTC
Location: Powell, TN, US
hazard: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
distribution: US Nationwide distribution in the states of LA,MO, MD, TN, UT.
event number: 99728
manufacturer: DeRoyal Industries Inc
recall number: Z-3256-2026
source status: Open, Classified
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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