# FDA recall Z-1583-2018

> **DeRoyal Industries Inc** · Class II · device recall initiated 2018-04-23.

## Product

DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502    Product Usage: general surgical

## Reason for recall

Non-sterile product was packaged inside a case that was labeled as sterile.

## Distribution

Honduras, Belgium, and The Netherlands

## Key facts

- **Recall number:** Z-1583-2018
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-23
- **Report date:** 2018-05-09
- **Termination date:** 2018-11-09

- **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-1583-2018

## Citation

> AI Analytics. FDA recall Z-1583-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1583-2018. Source: US FDA. Licensed CC0.

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