Lower riskMedical device recall · FDA · Published December 18, 2018
Insulet Omnipod DASH Insulin System Recall: Communication Errors May Cause Inaccurate
Insulet recalls Omnipod DASH insulin systems with specific lot numbers due to potential communication errors that could lead to inaccurate insulin readings. Affected users should contact Insulet for details.
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
Take action
Contact the company
📍Recalling firmInsulet Corporation600 Technology Park Dr Ste 200 · Billerica, MA 01821-4150
“Insulet Omnipod DASH Insulin System Recall: Communication Errors May Cause Inaccurate.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69317-insulet-omnipod-dash-insulin-system-recall-communication-errors-may-cause. Based on FDA recall #Z-0347-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0347-2020%22&limit=1).
The FDA announced on 2018-12-18 that Insulet Corporation is recalling the Omnipod DASH Insulin Management System due to a potential communication interruption following a bolus command. This hazard may result in inaccurate information presented in insulin on board, last bolus field or bolus history.
According to the FDA, there is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
Context
GovInfoNow's records show Insulet Corporation has 11 other recalls on record since 2020-02-13. Recent brand recalls include the 2026-05-20 Insulet Omnipod 5 Pods Recall for insulin leak risk, the 2026-03-12 Insulet Omnipod 5 Pods Recall for internal leak risk, and the 2025-09-11 Insulet Omnipod 5 App recall for insulin entry errors. Other recent recalls of similar products include the 2026-05-27 Medtronic MiniMed 780G Insulin Pump Recall, the 2026-02-13 Medtronic MiniMed 630G Insulin Pump Recall, and the 2026-07-13 Medtronic MiniMed 780G Insulin Pump Recall.
How to tell if you have this one
Check your Omnipod DASH system's product catalog number (18239 M/D: PDM USA1 D001 MG USA1) and lot numbers (L000120 to L000136). The recall covers specific lot numbers listed in the official notice.
Brand
Insulet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify your Omnipod DASH system's product catalog number and lot numbers to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 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-0347-2020 (December 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0347-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.