Z-3256-2026 Class II Ongoing
FDA device recall Z-3256-2026 was initiated by DeRoyal Industries Inc on Aug 20, 2026 and is designated Class II. Reason for recall: Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle. The recall status is ongoing. Affected quantity: 7 cases, 140 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 20, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 cases, 140 units
Product Description
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Reason for Recall
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Distribution Pattern
US Nationwide distribution in the states of LA,MO, MD, TN, UT.
Code Information
DI: 00749756046077/Lot # 63426754
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3256-2026
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026