Novo Nordisk Inc: Medical Device Recall in 2017 - (Recall #: Z-0206-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 5, 2017

Date Posted: December 13, 2017

Recall Number: Z-0206-2018

Event ID: 77704

Reason for Recall:

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

Status: Terminated

Product Quantity: 16,557 units

Code Information:

U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated