FDA-Device2026-09-30Class IIPROCESSING DEFECT
DeRoyal myocardial temperature probes recalled for incorrect needle size
What this means
DeRoyal Industries myocardial temperature probes (400 Series, Lot #63426754) contain an 18mm needle instead of the correct 15mm needle. This mismatch could affect proper placement and function during cardiac temperature monitoring.
- If you received or use this product, do not use it and contact DeRoyal Industries or the FDA.
- Check your inventory against Lot #63426754 and device identifier 00749756046077.
The agency's original wording
Hazard
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Affected count
7 cases, 140 units
Manufactured in
200 Debusk Ln, Powell, TN, United States
Products
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3256-2026Want us to check the next one for you?
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