FDA Device recall Z-0206-2018
Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for singl…
- FDA Device
- Class II
- terminated
- Published 2017-12-13
On 2017-12-13 the FDA classified a Class II recall of Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for singl… by Novo Nordisk, citing A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0206-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-05 |
| Published | 2017-12-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Novo Nordisk |
| Distribution | US |
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
A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
Identifiers
| code_info | U.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Novo Nordisk
- Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark,…
FDA Drug · Class II · 2026-01-07 · Novo Nordisk - Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, P…
FDA Drug · Class II · 2026-01-07 · Novo Nordisk - Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Ma…
FDA Drug · Class I · 2021-04-21 · Novo Nordisk
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.