← FDA ENFORCEMENT
Z-3256-2026Class II
DeRoyal Industries Inc
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
DeRoyal Industries Inc
Product type
Device
Status
Ongoing
Report date
2026-09-30
Distribution
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Firm state
TN
Product quantity
7 cases, 140 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Product description
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Code / lot info
DI: 00749756046077/Lot # 63426754
Other recalls SPEQ maps to Documentation & Change Control
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See all Documentation & Change Control recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →