Recall Z-3256-2026— DeRoyal Industries Inc

Name: FDA recall Z-3256-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Class II · Ongoing

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2026-08-20. It names one FDA 510(k) clearance: K925792. Product: 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..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-08-20
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K925792 — EXAC-TEMP & CLINI-TEMP TYMPANIC & MYOCARDIAL PROBEDeroyal Industries, Inc.·cleared 1994-04-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.