Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Omnipod DASH Insulin Management System Recalled by Insulet Corporation Due to There is a potential for a communication interruption...

Date: December 18, 2018
Company: Insulet Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Insulet Corporation directly.

Affected Products

Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1

Quantity: 264

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Insulet Corporation

Insulet Corporation has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report