Dial-A-Dose Insulin Delivery Device — Class II medical device recall Z-0206-2018
Terminated recall by Novo Nordisk Inc, reported 2017-12-13, distributed nationwide. A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.
| Recall number | Z-0206-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novo Nordisk Inc, Plainsboro, NJ, United States |
| Recall initiated | 2017-07-05 |
| Classified | 2017-12-07 |
| Reported by FDA | 2017-12-13 |
| Terminated | 2019-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 16,557 units |
| Reason classes | packaging, device malfunction |
| Lot numbers | EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, FVG8135 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0206-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.