Ref: 81-030415 recallZ-3256-2026 · DeRoyal Industries Inc · initiated Aug 20, 2026
Class II Open, Classified All recalls posted in September 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
FDA root cause category: Under Investigation by firm
What the company is doing
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]
Recall details
- Recall number
- Z-3256-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 20, 2026
- Posted by the FDA
- Sep 22, 2026
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 7 cases, 140 units
- Product code
- FLL
- FDA submissions
- K925792
- Distribution
- US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Product description
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Code information (models, lots, serial numbers)
DI: 00749756046077/Lot # 63426754
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 81-030415Deroyal Industries, Inc. · Thermometer, electronic, clinical1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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