# FDA recall Z-2078-2021

> **Owen Mumford USA, Inc.** · Class II · device recall initiated 2021-05-26.

## Product

Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

## Reason for recall

Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.

## 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, TX, UT, VA, VT, WA, and WV.

## Key facts

- **Recall number:** Z-2078-2021
- **Recalling firm:** Owen Mumford USA, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-05-26
- **Report date:** 2021-07-21

- **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-2078-2021

## Citation

> AI Analytics. FDA recall Z-2078-2021. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-2078-2021. Source: US FDA. Licensed CC0.

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