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Home › FDA recalls › REF: 81-030415 Myocardial Probe Non-Pyrogenic
CLASS II · ModerateFDA

DeRoyal Industries Inc recalls REF: 81-030415 Myocardial Probe Non-Pyrogenic

📅 Aug 20, 2026 · 📍 Nationwide
Recalling company
DeRoyal Industries Inc
Product
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Reason
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 20, 2026
Reported
Sep 30, 2026
Distribution
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Status
Ongoing
Quantity
7 cases, 140 units
Lot / codes
DI: 00749756046077/Lot # 63426754
Company location
Powell, TN
Recall type
Voluntary: Firm initiated
Recall number
Z-3256-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3256-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.