FDA Device recall Z-3256-2026
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series by Deroyal Industries, citing myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3256-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-20 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Deroyal Industries |
| Distribution | US |
Product
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Reason
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Identifiers
| code_info | DI: 00749756046077/Lot # 63426754 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Deroyal Industries
- DeRoyal Industries Inc
FDA Device · Class II · 2026-06-10 · Deroyal Industries - DeRoyal REF 71-C5100NS Tubing, Suction, Connector
FDA Device · Class II · 2025-03-12 · Deroyal Industries - DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
FDA Device · Class II · 2025-02-26 · Deroyal Industries - DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
FDA Device · Class II · 2024-11-13 · Deroyal Industries - DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
FDA Device · Class II · 2024-11-13 · Deroyal Industries
All Deroyal Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3256-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.