# FDA recall Z-1318-2018

> **Reliance Medical Products Inc** · Class II · device recall initiated 2017-12-06.

## Product

Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)       The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.

## Reason for recall

Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm was notified by distributor that Refractor Suspension Arm fell on a patient s lower torso along with the arm housing

## Distribution

Worldwide Distribution - USA(nationwide) Distribution to the states of :  NJ, CA, OH, VA, MA, MN, IL , UT, TN, AR, LA, AZ, PA, TX, IA and HI., and to the countries of :  Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia and Jordan.

## Key facts

- **Recall number:** Z-1318-2018
- **Recalling firm:** Reliance Medical Products Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-06
- **Report date:** 2018-04-18
- **Termination date:** 2019-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mason, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1318-2018

## Citation

> AI Analytics. FDA recall Z-1318-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1318-2018. Source: US FDA. Licensed CC0.

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