Insulet Corporation recalls 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM…
The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a…
Read the official notice →- Date
- 2022-11-23
- Country
- United States
- Brand
- Insulet
- Product
- 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM…
- Classification
- Class I
- Units
- Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Insulet recalls
- 2026-04-22
USInsulet Corporation recalls Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus…
- 2025-10-22
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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 magnify the visual field…
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a…
- 2025-07-02
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Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product…
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if…
FDA · DeviceInsulet CorporationUS market only- Although there are 122823 downloads of the application, our…Official notice → - 2024-01-10
- US
Insulet Corporation recalls Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package…
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on…
FDA · DeviceInsulet CorporationWorldwide distribution - US Nationwide and the countries of Germany and UK.Official notice → - 2023-09-27
- US
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which…
- 2022-12-14
- US
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor,…
The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the…
Other drugs & medical recalls in the United States
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Carefusion 2200 Inc recalls CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
FDA · DeviceCarefusion 2200 IncUS and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia,…Official notice → - US
Canadian Hospital Specialties recalls MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
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- US
Covidien, LP recalls Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L,…
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign…
FDA · DeviceCovidien, LPDomestic distribution nationwide. Foreign distribution to Australia Austria…Official notice → - US
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