# FDA recall Z-1604-2020

> **DeRoyal Industries Inc** · Class II · device recall initiated 2020-02-27.

## Product

DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.

## Reason for recall

One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.

## Distribution

VA, CA, FL, AZ

## Key facts

- **Recall number:** Z-1604-2020
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-27
- **Report date:** 2020-04-08
- **Termination date:** 2022-05-10

- **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-1604-2020

## Citation

> AI Analytics. FDA recall Z-1604-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1604-2020. Source: US FDA. Licensed CC0.

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