Use cautionMedical device recall · FDA · Published February 13, 2020
Insulet Omnipod DASH PDM May Give Wrong Insulin Dose - Hypoglycemia Risk
Insulet recalls Omnipod DASH Personal Diabetes Manager (PDM) software versions 1.0.50 and earlier due to potential inaccurate insulin dosing, which could cause dangerous low or high blood sugar levels.
In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.
Take action
Contact the company
📍Recalling firmInsulet Corporation100 Nagog Park · Acton, MA 01720-3440
✎ GovInfoNow plain-language explainer
Insulet is recalling Omnipod DASH Personal Diabetes Manager devices with software versions 1.0.50 and earlier because they may suggest incorrect insulin doses when blood glucose readings are more than 10 minutes old. This could lead to dangerously low or high blood sugar levels if the user administers the dose. Read more at govinfonow.com/recall/65841-insulet-omnipod-dash-pdm-may-give-wrong-insulin-dose-hypoglycemia.
“Insulet Omnipod DASH PDM May Give Wrong Insulin Dose - Hypoglycemia Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65841-insulet-omnipod-dash-pdm-may-give-wrong-insulin-dose-hypoglycemia. Based on FDA recall #Z-1553-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1553-2020%22&limit=1).
The FDA announced on Feb. 13, 2020, that Insulet Corporation is recalling Omnipod DASH Personal Diabetes Managers due to a hazard of inaccurate bolus amounts. The agency said the device may suggest incorrect dosages based on outdated blood glucose values. Owners should contact Insulet for a software update.
How to tell if you have it
Brand: Insulet
Product: Omnipod DASH Personal Diabetes Manager (PDM)
Lots: L000120 through L000199, L000213, L000214, L000204
The hazard
The FDA said the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old. This occurs when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.
Context
GovInfoNow's records show Insulet Corporation has 11 other recalls on record since Dec. 18, 2018. Recent brand recalls include an Omnipod 5 Pods recall on May 20, 2026, for insulin leak risk and another on March 12, 2026, for internal leak risk. Other recent recalls of similar products include Medtronic Paradigm Insulin Pumps Recall (Feb. 13, 2026), Medtronic MiniMed 530G Insulin Pump Recall (Feb. 13, 2026), and Medtronic MiniMed 630G Insulin Pump Recall (Feb. 13, 2026).
How to tell if you have this one
Check for Omnipod DASH PDM devices with software version 1.0.50 or earlier. The product was sold in the US and EU with specific catalog numbers listed in the recall notice.
Brand
Insulet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for the software version on your Omnipod DASH PDM device; versions 1.0.50 and earlier are affected.
Update Software
Update to software version 1.0.51 or later to fix the issue, as provided by Insulet.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution. Foreign distribution to Italy, Netherlands, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1553-2020 (February 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1553-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.