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

Class II
Recalling firm
DeRoyal Industries Inc
Reason for recall
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Affected products (lot / model / serial)
DI: 00749756046077/Lot # 63426754
Units affected
7 cases, 140 units
Distribution pattern
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Firm location
Powell, TN, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
E-Mail
Product type
Devices
Status
Ongoing
Recall number
Z-3256-2026
Recall initiated
August 20, 2026
FDA classification date
September 22, 2026
FDA report date
September 30, 2026
FDA event ID
99728
Last updated on HTM Vibe
October 6, 2026
View on openFDA