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…
Read the official notice →- Date
- 2025-10-22
- Country
- United States
- Brand
- Insulet
- Product
- 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…
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-07-08
USInsulet Corporation recalls Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump…
FDA · DeviceInsulet CorporationWorldwide distribution - US Nationwide and the countries of Austria,…Official notice →- 2026-04-22
- US
Insulet 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…
- 2025-07-02
- US
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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- US
Medline Industries, LP recalls Medline Adult Anesthesia Set, REF DYNJ39985G
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
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Iantrek Inc. recalls C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional…
Potential for compromised integrity of the sterile packaging.
FDA · DeviceIantrek Inc.US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID,…Official notice → - US
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The fastening post hardware could loosen allowing the fastening post to detach from the cot
FDA · DeviceFerno-Washington IncUS Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IS, IL,…Official notice → - US
Contego Medical LLC recalls Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF:…
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The…
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Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
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MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536,…
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may…
FDA · DeviceMICROVENTION INC.Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL,…Official notice →