FDAFDA recall Z-3256-2026 · Sep 30, 2026
DeRoyal Industries Inc: REF: 81-030415 Myocardial Probe Non-Pyrogenic recall
Recall found
Product
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Reason for recall
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- DI: 00749756046077/Lot # 63426754
- Quantity
- 7 cases, 140 units
- Distribution
- US Nationwide distribution in the states of LA,MO, MD, TN, UT.
- Recalling firm
- DeRoyal Industries Inc, Powell, TN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-20
Source: openFDA enforcement record Z-3256-2026 · search recall number Z-3256-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.