Z-3256-2026Class II

REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series

Name: Z-3256-2026 REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Creator: DeRoyal Industries Inc
Published: 2026-08-20
License: https://open.fda.gov/license/

DeRoyal Industries Inc / initiated 2026-08-20 / Open, Classified

FDA source

Recall record

Recall number: Z-3256-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-20
Posted: 2026-09-22
Recalling firm: DeRoyal Industries Inc
Product: REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Product code: FLL Continuous Measurement Thermometer
Reason for recall: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
FDA root cause: Under Investigation by 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]
Quantity in commerce: 7 cases, 140 units
Distribution: US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Product codes and lots: DI: 00749756046077/Lot # 63426754

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3256-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3256-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-22

Product code FLL

K925792Class IIExac-Temp & Clini-Temp Tympanic & Myocardial ProbeDeroyal Industries, Inc. / cleared 1994-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)