REF: 81-030415 Myocardial Probe Non-Pyrogenic recall (DeRoyal Industries Inc)
Medical deviceClass IIOngoing
Summary: DeRoyal Industries Inc is recalling 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.
What is being recalled
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Why
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of LA,MO, MD, TN, UT. (states named: Louisiana, Maryland, Missouri, Tennessee, Utah)
How to tell if yours is affected
DI: 00749756046077/Lot # 63426754
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3256-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 20, 2026 |
| Reported | September 30, 2026 |
| Company | DeRoyal Industries Inc |
| Company location | Powell, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 cases, 140 units |
More recalls from DeRoyal Industries Inc · all medical device recalls · recalls from August 2026