Insulet Corporation: 10 recalls on record

Recalls filed with 1 agency: FDA (10).

First recall on record: November 13, 2013. Most recent: July 8, 2026.

Risk classification: Class I: 7 · Class II: 3

Most recent recalls

DateAgencyProduct
July 8, 2026FDAOmnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), P…Z-2604-2026
July 8, 2026FDAOmnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-…Z-2603-2026
July 8, 2026FDAOmnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), PO…Z-2605-2026
April 22, 2026FDAOmnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Z-1797-2026
January 10, 2024FDAOmnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current…Z-0591-2024
November 23, 2022FDA18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final …Z-0154-2023
April 1, 2020FDAOmnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D…Z-1553-2020
December 23, 2015FDAOmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The …Z-0394-2016
November 13, 2013FDAOmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490…Z-0166-2014
November 13, 2013FDAOmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starte…Z-0165-2014

Questions about this company

How many recalls does Insulet Corporation have?
Recalert has 10 U.S. recalls on record for Insulet Corporation, published between November 13, 2013 and July 8, 2026.
What was the most recent Insulet Corporation recall?
FDA recall Z-2604-2026, published July 8, 2026: Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (1…
Which agencies have handled Insulet Corporation recalls?
Insulet Corporation appears as the recalling firm in recalls from: FDA (10).

Do you carry products from Insulet Corporation? Check your whole catalog free against 80,000+ recalls.

Paste up to 100 UPCs or SKUs and see which ones match a CPSC, FDA, NHTSA or FSIS recall. No account needed.

Check my catalog free

Want it checked every night instead? Starter watches 500 SKUs for $29/month. See plans

Related companies