# FDA recall Z-3256-2026

> **DeRoyal Industries Inc** · Class II · device recall initiated 2026-08-20.

## Product

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

US Nationwide distribution in the states of LA,MO, MD, TN, UT.

## Key facts

- **Recall number:** Z-3256-2026
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-20
- **Report date:** 2026-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3256-2026

## Citation

> MORVS. FDA recall Z-3256-2026. Retrieved 2026-10-12 from https://api.morvs.ai/recall/Z-3256-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
