CLASS II Device recall · Reported 13 Dec 2017 · FDA Enforcement Report

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

Novo Nordisk is recalling Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders, distributed nationwide in the US. The recall was initiated on 5 Jul 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesU.S. batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 & FVG8135

Quantity recalled16,557 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0206-2018
FDA event ID: 77704
Recalling firm: Novo Nordisk, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 5 Jul 2017
FDA classified: 7 Dec 2017
Reported: 13 Dec 2017
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Device Malfunction
Device type: Syringes & Needles

Timeline

5 Jul 2017	Recall initiated by company
7 Dec 2017	Classified by FDA	+155 days
13 Dec 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide distribution

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Novo Nordisk

All 18

Reported	Class	Recall	Company	Reason	Where
7 Jan 2026Drug	CLASS II	Wegovy (semaglutide) Injection, 0.5 mg/-Dose Prefilled Pens recalled	Novo Nordisk	Particulate Matter	Nationwide
7 Jan 2026Drug	CLASS II	Wegovy (semaglutide) Injection, 1 mg/-Dose Prefilled Pens recalled	Novo Nordisk	Particulate Matter	Nationwide
21 Apr 2021Drug	CLASS I	Tresiba FlexTouch (insulin degludec injection)/mL recalledTresiba	Novo Nordisk	Temperature Abuse	Nationwide
21 Apr 2021Drug	CLASS I	NovoLog (Insulin aspart) Injection/mL (U-100) recalled by Novo NordiskInsulin Diluting Medium For Novolog	Novo Nordisk	Temperature Abuse	Nationwide
21 Apr 2021Drug	CLASS I	Tresiba FlexTouch (insulin degludec injection)/mL recalledTresiba	Novo Nordisk	Temperature Abuse	Nationwide

Other Syringes & Needles recalls

All 1,065

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	Medrad¿ Stellant Flex Syringe Kit used recalled by Bayer Medical Care	Bayer Medical Care	Sterility	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
23 Sep 2026Device	CLASS II	IV Sets with drip chambers recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide