Omnipod DASH Personal Diabetes Manager — Class II medical device recall Z-1553-2020
Terminated recall by Insulet Corporation, reported 2020-04-01, distributed nationwide. In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose val
| Recall number | Z-1553-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Acton, MA, United States |
| Recall initiated | 2020-02-13 |
| Classified | 2020-03-20 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2021-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, IT, NL |
| UPC / GTIN / UDI-DI | 10385082000009 |
| Lot numbers | L000120, L000121, L000122, L000123, L000124, L000125, L000126, L000127, L000128, L000129, L000130, L000131, L000132, L000133, L000134, L000135, L000136, L000137, L000138, L000139, L000140, L000141, L000142, L000143, L000144, L000145, L000146, L000147, L000148, L000149, L000150, L000151, L000152, L000153, L000154, L000155, L000156, L000157, L000158, L000159 and 43 more |
| Model numbers | 18239, INT1-D001-MG, INT1-D001-MM, PDM-USA1-D001-MG-USA1, PT-000010, PT-000011 |
Product
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1553-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.