# FDA recall Z-0206-2018

> **Novo Nordisk Inc** · Class II · device recall initiated 2017-07-05.

## Product

Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders    Product Usage:  The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog¿, 100 units/mL (Ux100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments.

## Reason for recall

A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.

## Distribution

Nationwide distribution

## Key facts

- **Recall number:** Z-0206-2018
- **Recalling firm:** Novo Nordisk Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-05
- **Report date:** 2017-12-13
- **Termination date:** 2019-04-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0206-2018

## Citation

> AI Analytics. FDA recall Z-0206-2018. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0206-2018. Source: US FDA. Licensed CC0.

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