Insulet Recalls Omnipod DASH User Guides Due to Decimal Error
Insulet Corporation is recalling 21,723 Omnipod DASH User Guides distributed outside the US due to a misprint regarding decimal separators that could lead to incorrect bolus delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device documentation error that could lead to incorrect insulin dosing and hypoglycemia, a risk-of-harm scenario where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Insulet Corporation is recalling 21,723 Omnipod DASH Insulin Management System User Guides. These guides were distributed to Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland. The recall is limited to Outside the US (OUS) markets.
The recall is due to a misprint on page 6 of the User Guide. The text incorrectly states that the comma (,) is not used for the decimal on the Personal Diabetes Manager (PDM), when in fact it is the period (.) that is not used. If a user follows the incorrect instruction and uses a period as the decimal separator when entering a bolus value, the device will not recognize the separator. This could result in the device interpreting the numbers entered after the period as part of the main value, leading to a larger bolus delivery than intended and potential hypoglycemia.
Consumers who have these specific user guides should stop using them for reference and contact Insulet Corporation for a replacement or further instructions. The affected part numbers include PT 000002, PT 000318, and PT 000319 in various language and country-specific revisions.
The recalled product
- Product
- Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
- Manufacturer
- Insulet Corporation
- Affected units
- 21,723
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part Number/Rev./Country: PT 000002 AUT DEU mg 1
- 2
- 3 Guide
- Dash User
- German Austria PT 000002 BEL DEU MG 1
- Dash User Guide
- Belgium Germany
- mgdl PT 000002 BEL FRE MG 1
- 3
- 4 Guide
- Belgium French
- mgdl PT 000002 BEL NLD MG 1
- Belgium Dutch
- mgdl PT 000002 DEU DEU mg 1
- German Germany
- mgdl PT 000002 DEU DEU mm 1
- mmoll PT 000002 DNK DANmm 1
- Danish Denmark PT 000002 FIN FIN mm 1
- Finnish Finland PT 000002 FRA FRE mg 1
- French France PT 000002 NLD NLD mm 1
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Insulet Corporation
See all →- SevereOmnipod Eros Pod Insulin Delivery Failure Risk
FDA (Devices) · 2026-07-08
- SevereOmnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
FDA (Devices) · 2026-07-08
- CriticalOmnipod DASH Pod insulin pump affected by external cannula damage
FDA (Devices) · 2026-07-08
- SevereOmnipod 5 insulin pods from 49 lots have torn internal cannulas
FDA (Devices) · 2026-04-22
- HighOmnipod 5 app recalled because magnifying a field duplicates typed digits
FDA (Devices) · 2025-10-22
Same hazard · incorrect dosing
See all →- HighDimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision
FDA (Devices) · 2023-03-22
- HighPhototherapy Units Recalled for Software Bug Causing Incorrect Dosing
FDA (Devices) · 2022-05-18
- HighCT5000 X-ray System Contrast Dose Calculation Error Under Pounds Setting
FDA (Devices) · 2021-08-25
- HighRoche CoaguChek XS PST Meters Recalled for Potential Unit Misinterpretation
FDA (Devices) · 2021-01-13
- HighInsulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error
FDA (Devices) · 2020-06-10