REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Published September 30, 2026 · Recall initiated: August 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- US Nationwide distribution in the states of LA,MO, MD, TN, UT.
- Lot
- DI: 00749756046077/Lot # 63426754
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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Questions about this recall
Was REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recalled?
Yes. FDA published recall Z-3256-2026 on September 30, 2026. Reported hazard: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
What should I do if I have this product?
Voluntary: Firm initiated · E-Mail
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