# FDA recall Z-0087-2018

> **Epimed International** · Class II · device recall initiated 2017-07-24.

## Product

RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter

## Reason for recall

Potential for partially incomplete seal of product, impacting sterility.

## Distribution

Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.

## Key facts

- **Recall number:** Z-0087-2018
- **Recalling firm:** Epimed International
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-24
- **Report date:** 2017-11-15
- **Termination date:** 2023-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Farmers Branch, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0087-2018

## Citation

> AI Analytics. FDA recall Z-0087-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0087-2018. Source: US FDA. Licensed CC0.

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