Insulet Corporation recalls
Every recall we track for Insulet Corporation — 15 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Insulet Corporation peaked in 2020 (3); 15 since 2017. 27% rated “stop using now”.
All FDA recall records for Insulet Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 1 | 2 | 0 | 3 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 1 | 1 | 0 | 0 | 2 |
| 2023 | 0 | 1 | 1 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 2 | 0 | 0 | 2 |
| 2026 (to date) | 3 | 1 | 0 | 0 | 4 |
What to do if you have a recalled Insulet Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Insulet Corporation recalls
12 shown- Use cautionMedical device
Insulet Corporation recalls Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729
Insulet recalls Omnipod 5 Pods with specific model numbers due to manufacturing defect causing insulin leaks, potentially leading to high blood sugar and serious health risks.
InsuletMay 20, 2026 - Stop using nowMedical device
Insulet Corporation recalls Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Insulet recalls Omnipod 5 Pods with a manufacturing defect causing insulin leaks that may lead to under-delivery or pump shutdown. Affected units include specific model numbers and lots from 2023-2024.
InsuletMar 12, 2026 - Use cautionMedical device
Insulet Corporation recalls The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to
Insulet recalls Omnipod 5 iOS app software versions 2.X.X due to potential insulin overdose from entry errors when using iPhone magnification. Affected users should contact Insulet for updates.
InsuletSep 11, 2025 - Use cautionMedical device
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all
Insulet recalls Omnipod 5 iOS App software (model PT-000664/M009-S-AP) due to a decimal separator issue that may cause insulin overdelivery and hypoglycemia. Affected users should contact Insulet for guidance.
InsuletMay 23, 2025 - Use cautionMedical device
Insulet Corporation recalls Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5
Insulet recalls Omnipod 5 App software versions 1.1-1.2.3 for potential insulin over-delivery if decimal point is missed during dose changes. Users should update to latest version via Google Play.
InsuletNov 30, 2023 - Lower riskMedical device
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System
Insulet recalls Omnipod 5 App for Android phones that may delay insulin control due to error messages. Users can switch to locked-down controller if needed. No serious injuries reported.
InsuletFeb 28, 2023 - Use cautionMedical device
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed
Insulet recalls Omnipod 5 insulin pumps with melting charging ports that may cause minor burns or charging failure. Affected units include specific product codes and serial numbers.
InsuletNov 14, 2022 - Stop using nowMedical device
Insulet Corporation recalls 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011:
Insulet recalls Omnipod Dash PDM insulin delivery systems with battery swelling, leaks, and overheating risks. Owners should stop using affected units immediately to prevent fire hazards.
InsuletOct 17, 2022 - Lower riskMedical device
Insulet Corporation recalls Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT
Insulet recalls Omnipod DASH insulin management system user guides with a misprint that could cause incorrect insulin doses and hypoglycemia for users outside the US. Affected guides include specific language versions sold in Canada, Germany, France, and other countries.
InsuletFeb 1, 2021 - Lower riskMedical device
Insulet Corporation recalls Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage:
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.
InsuletApr 2, 2020 - Use cautionMedical device
Insulet Corporation recalls Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D:
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.
InsuletFeb 13, 2020 - Lower riskMedical device
Insulet Corporation recalls Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
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.
InsuletDec 18, 2018
Insulet Corporation recall questions
How many recalls has Insulet Corporation had?
15 recalls from Insulet Corporation are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Insulet Corporation recall?
Insulet Corporation recalls Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729, dated May 20, 2026. Every Insulet Corporation recall is listed on this page, newest first.
What should I do if I have a recalled Insulet Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Insulet Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.