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

Medical DevicesSource: FDA (device) · Date: 2026-09-30

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
DeRoyal Industries Inc
Product
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Reason / hazard
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Recall initiated
2026-08-20
Code info
DI: 00749756046077/Lot # 63426754
Product quantity
7 cases, 140 units
Voluntary mandated
Voluntary: Firm initiated
City
Powell
State
TN
Country
United States
Event id
99728
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