DeRoyal Myocardial Probe 400 Series
Myocardial temperature probes contain an incorrect needle, an 18mm needle instead of a 15mm needle.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
DeRoyal Industries Inc of Powell, Tennessee recalled REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series because the myocardial temperature probes contain an incorrect needle, an 18mm needle instead of a 15mm needle. The recall began on August 20, 2026, and was added to the FDA's Enforcement Report on September 22, 2026. The recalled units were distributed in Louisiana, Maryland, Missouri, Tennessee and Utah, involving 7 cases and 140 units.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
- UDI-DI
- 00749756046077
- 63426754
Details
- Company began the recall
- Event ID
- 99728
- Recall No.
- Z-3256-2026
- Company
- DeRoyal Industries IncPowell, Tennessee
- Hazard
- Device defect
- Quantity recalled
- 7 cases, 140 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
