# FDA recall Z-0381-2018

> **Owen Mumford USA, Inc.** · Class II · device recall initiated 2017-11-06.

## Product

Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles.    Product Usage:  Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.

## Reason for recall

Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility.  This may appear as discoloring or yellowing of the device's protective seal.

## Distribution

US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV

## Key facts

- **Recall number:** Z-0381-2018
- **Recalling firm:** Owen Mumford USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-06
- **Report date:** 2018-01-24
- **Termination date:** 2021-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0381-2018

## Citation

> AI Analytics. FDA recall Z-0381-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0381-2018. Source: US FDA. Licensed CC0.

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