# FDA recall Z-3180-2026

> **embecta Medical II LLC** · Class II · device recall initiated 2023-07-26.

## Product

EWO_02513 (Catalog number 320122)  For Investigational Use Only  Nano Un-Cannulated Demo Samples  Quantity 100

## Reason for recall

Retrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices.

## Distribution

US Nationwide distribution in the states of MA, KY, CT, TX, NJ, OH, MN, LA, IN, NH, AL, CA, NY, FL, NC, MI, SC, AZ, VA, GA, PA, MO.

## Key facts

- **Recall number:** Z-3180-2026
- **Recalling firm:** embecta Medical II LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-26
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3180-2026

## Citation

> MORVS. FDA recall Z-3180-2026. Retrieved 2026-10-25 from https://api.morvs.ai/recall/Z-3180-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*