REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
FDA Recall Z-3256-2026 · Posted 2026-09-22
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Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeFLL
Date Initiated2026-08-20
Product Quantity7 cases, 140 units
Reason for Recall
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Firm Action
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 [email protected] 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 [email protected] or by phone 865-362-6206 or email us at [email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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