Lower riskMedical device recall · FDA · Published April 2, 2020
Insulet Omnipod DASH Insulin System Recall: Bolus Calculator Accuracy Issues
Insulet recalls Omnipod DASH insulin systems with mg/dL configuration due to potential bolus calculation errors after 2 months of use. Affected units may require replacement.
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
Take action
Contact the company
📍Recalling firmInsulet Corporation100 Nagog Park · Acton, MA 01720-3440
“Insulet Omnipod DASH Insulin System Recall: Bolus Calculator Accuracy Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65576-insulet-omnipod-dash-insulin-system-recall-bolus-calculator-accuracy-issues. Based on FDA recall #Z-2164-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2164-2020%22&limit=1).
The FDA announced on April 2, 2020, that Insulet Corporation voluntarily recalled the Omnipod DASH Insulin Management System (mg/dL configuration) due to a data processing hazard. The agency said the defect may cause the Bolus Calculator to inaccurately subtract insulin on board before suggesting a bolus amount.
How to tell if you have it
Brand: Insulet
Product: Omnipod DASH Insulin Management System (mg/dL configuration)
Catalog Number: PT000010
M/D: INT1D001MG
Lot Numbers: L000202
The hazard
According to the FDA, after the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amount of IOB before suggesting a bolus amount.
Context
GovInfoNow's records show Insulet Corporation has 11 other recalls on record since December 18, 2018. Other recent recalls include the Insulet Omnipod 5 Pods Recall dated May 20, 2026, and the Insulet Omnipod 5 App recall dated September 11, 2025. Similar recent recalls of comparable devices include the Medtronic MiniMed 780G Insulin Pump Recall on May 27, 2026, and the Beta Bionics iLet Bionic Pancreas Software recall on March 12, 2026.
How to tell if you have this one
Check for the Omnipod DASH insulin system with mg/dL configuration, catalog number PT000010, and model M/D: INT1D001MG. The lot number L000202 is also associated with this recall.
Brand
Insulet
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
The products were distributed to the following foreign countries: Italy, Netherlands, UK.
Recall number
Product, codes & lots
Quantity
Z-2164-2020
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.; UDI: PT - 000010 - 10385082000139; Lot Numbers: L000202
400
Z-2165-2020
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.; UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210
1773
Based on the official FDA remedy
What to do — step by step
Check Device Status
Verify if your Omnipod DASH system has been in use for over two months and has the specified configuration and catalog number.
How this recall unfolded
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-2164-2020 (April 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2164-2020 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.