Device recall
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
- Recall number
- Z-3256-2026
- Event id
- 99728
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- DeRoyal Industries Inc
- Report date
- Sep 30, 2026
- Posted
- Sep 22, 2026
- Initiated
- Aug 20, 2026
- Center classification date
- Sep 22, 2026
- Product code
- FLL
- Device type
- Continuous Measurement Thermometer
- Reason
- Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
- Root cause
- Under Investigation by firm
- Quantity
- 7 cases, 140 units
- Code info
- DI: 00749756046077/Lot # 63426754
- Distribution
- US Nationwide distribution in the states of LA,MO, MD, TN, UT.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K925792
- Location
- Powell, TN, United States