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Use caution Medical device recall · FDA · Published July 5, 2017

Novo Nordisk Recalls Dial-A-Dose Insulin Devices for Cracking Hazard

Novo Nordisk recalls 16,557 Dial-A-Dose insulin delivery devices due to cracking risks. Check your batch numbers and usage instructions immediately.

🇺🇸 FDA recall #Z-0206-2018Medical deviceNovo Nordisk ›
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Recalling firmNovo Nordisk Inc800 Scudders Mill Rd · Plainsboro, NJ 08536-1606
✎ GovInfoNow plain-language explainer

What happened, in plain English

Novo Nordisk Inc. is recalling a small number of Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders because they may crack or break when exposed to certain chemicals, such as cleaning agents. The affected units are the NovoPen Echo re-usable pen injectors distributed nationwide. No remedy details are currently provided in the record. Read more at govinfonow.com/recall/73460-novopen-echo-insulin-cartridge-holders-recall-cracking-risk-from-cleaning.

Source Summary by GovInfoNow · govinfonow.com/recall/73460-novopen-echo-insulin-cartridge-holders-recall-cracking-risk-from-cleaning · Updated October 13, 2026 · FDA enforcement record: FDA #Z-0206-2018

Cite this page

“Novo Nordisk Recalls Dial-A-Dose Insulin Devices for Cracking Hazard.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/73460-novopen-echo-insulin-cartridge-holders-recall-cracking-risk-from-cleaning. Based on FDA recall #Z-0206-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2018%22&limit=1).

Why it’s dangerous

The plastic cartridge holders in a small number of batches can crack or break if they come into contact with specific chemicals, including some cleaning agents. This structural failure could compromise the integrity of the insulin delivery system during use.

Who’s affected

Diabetics who use the NovoPen Echo re-usable pen injector for self-injection of insulin doses ranging from 0.5 to 30 units. The risk applies specifically to users who may have exposed the device to certain cleaning agents.

How to tell if you have this one

Check if you have a NovoPen Echo re-usable pen injector for single patient use. Verify the U.S. batch numbers on your device against this list: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, and FVG8135.

  • Brand
    Novo Nordisk
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Batch Numbers

    Verify your device's U.S. batch number against the recalled list: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, and FVG8135.

  2. Avoid Certain Chemicals

    Do not expose the device to certain chemicals or cleaning agents that may cause it to crack or break.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jul 5, 201712. FDA classified it Class II: Dec 7, 201723. Published in FDA’s Enforcement Report: Dec 13, 201734. FDA terminated the recall: Apr 9, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Where were these products sold?

The devices were distributed nationwide across the United States.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0206-2018 (July 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0206-2018 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA