DeRoyal Industries Inc recalls REF: 81-030415 Myocardial Probe Non-Pyrogenic

Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.

On August 20, 2026, DeRoyal Industries Inc. issued a Urgent Medical Device Recall via Email. DeRoyal ask consignees to take the following actions: 1) Identify affected product numbers in your inventory and place in quarantine to prevent further use. 2) Please return the completed Notice of Return form to DeRoyal via fax to 865-362-3716 or recalls@deroyal.com no later than September 15, 2026. Please complete the form even if you no longer have any inventory. 3) If you distributed this product to other facilities or departments within your institution, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us 4) If you have questions regarding the recall, please contact Jennifer Marsh at jmarsh@deroyal.com or by phone 865-362-6206 or email us at recalls@deroyal.com

• FDA enforcement recordOfficial FDA database entry for Z-3256-2026
• FDA 510(k) clearance · K925792The device's official FDA premarket clearance record
• FDA device classification · FLLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.2910The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find DeRoyal Industries IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.