| | Class 2 Device Recall Myocardial Probe NonPyrogenic, 400 Series |  |
| Date Initiated by Firm | August 20, 2026 |
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| Date Posted | September 22, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3256-2026 |
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| Recall Event ID |
99728 |
| 510(K)Number | K925792 |
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| Product Classification |
Continuous Measurement Thermometer - Product Code FLL
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| Product | REF: 81-030415
Myocardial Probe Non-Pyrogenic , 400 Series |
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| Code Information |
DI: 00749756046077/Lot # 63426754
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| FEI Number |
1043214
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Recalling Firm/
Manufacturer |
DeRoyal Industries Inc
200 Debusk Ln
Powell
TN
37849-4703
|
| For Additional Information Contact | Ms. Theresa Marsee
865-938-7828 |
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Manufacturer Reason
for Recall | Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 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
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| Quantity in Commerce | 7 cases, 140 units |
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| Distribution | US Nationwide distribution in the states of LA,MO, MD, TN, UT. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = FLL
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