Z-0206-2018Class II

Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders

Name: Z-0206-2018 Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders
Creator: Novo Nordisk Inc
Published: 2017-07-05
License: https://open.fda.gov/license/

Novo Nordisk a/S / initiated 2017-07-05 / Terminated / root cause: design

FDA source

Novo Nordisk Inc began a recall of 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... on 2017-07-05. FDA classified it as Class II and gives the reason as "A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0206-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-05
Posted: 2017-12-07
Terminated: 2019-04-09
Recalling firm: Novo Nordisk a/S
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.
Product code: FMF Syringe, Piston
Reason for recall: A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
Root cause tag: design
FDA root cause: Device Design
Action: Novo Nordisk a Urgent Medical Device Letter dated July 10, 2017 to customers. The letter identified the affected product, problem and actions to be taken. In the United States, customers with diabetes using a NovoPen Echo from one of the affected batches listed are instructed to call Novo Nordisk at 1-855-419-8827 between 8 am and 6 pm EDT to get a replacement cartridge holder. For questions specific to the recall, please call 1-855-419-8827. If you have any other general questions or concerns, please contact Novo Nordisk Customer Care at 1-800-727-6500, Monday-Friday, 8:30 am 6 pm EDT. **Healthcare Providers/Wholesaler/Retail Customers: Novo Nordisk requested these groups: 1) Immediately stop distribution of the affected batches and quarantine any quantities of these batches remaining in your control. 2) Conduct a physical count and record this data on the included Business Reply Card and the Packing Slip. 3) Mail the postage paid Business Reply Card even if you do not have the recalled product in your inventory. 4) Return the recalled product and the Packing Slip using the prepaid FedEx Authorized Return Service shipping label to the following address: FedEx Supply Chain 6101 North 64th Street Milwaukee, WI, 53218. Customers with any questions regarding the recall process, please call FedEx Supply Chain directly at 855-419-8827, Monday Friday 8am 6pm EST.
Quantity in commerce: 16,557 units
Distribution: Nationwide distribution
Product codes and lots: U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0206-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0206-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-07

Product code FMF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)