Use caution Medical device recall · FDA · Published November 14, 2022

Insulet Omnipod 5 Controller Charging Port Melting Risk

Insulet recalls Omnipod 5 insulin pumps with melting charging ports that may cause minor burns or charging failure. Affected units include specific product codes and serial numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0423-2023Medical device Insulet ›

Use caution until it’s fixed

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 Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.

Take action

Contact the company

Recalling firmInsulet Corporation100 Nagog Park · Acton, MA 01720-3440

✎ GovInfoNow plain-language explainer

Insulet is recalling Omnipod 5 insulin pumps where the charging port can melt or discolor due to heat. This may cause minor burns or prevent the pump from charging, requiring a backup insulin plan. Read more at govinfonow.com/recall/59376-insulet-omnipod-5-controller-charging-port-melting-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/59376-insulet-omnipod-5-controller-charging-port-melting-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0423-2023

Cite this page

“Insulet Omnipod 5 Controller Charging Port Melting Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59376-insulet-omnipod-5-controller-charging-port-melting-risk. Based on FDA recall #Z-0423-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0423-2023%22&limit=1).

The FDA announced on November 14, 2022, that Insulet Corporation is voluntarily recalling Omnipod 5 Automated Insulin Delivery Systems due to melting or deforming charging ports. The hazard includes potential minor burns and failure to charge the device.

How to tell if you have it

Brand: Insulet
Product: Omnipod 5 Automated Insulin Delivery System
Catalog numbers: PT-000409, PT-000428, PT-000429
Units affected: 129,086

The hazard

The Omnipod 5 Controller charging port and cable may melt, deform, or discolor from heat generated by increased resistance. This excess heat may cause minor burns if touched, and the controller may fail to charge, requiring users to switch to a backup insulin plan.

Context

GovInfoNow's records show Insulet Corporation has 11 other recalls on record since December 18, 2018. Other recent recalls of similar products include Insulet Omnipod 5 Pods Recall: Insulin Leak Risk from Manufacturing Defect (May 20, 2026), Insulet Omnipod 5 Pods Recall: Internal Leak Risk from Manufacturing Defect (March 12, 2026), and Insulet Omnipod 5 App: Insulin Entry Errors Risk Hypoglycemia (September 11, 2025).

How to tell if you have this one

Check for melting, discoloring, or deformation in the charging port of your Omnipod 5 Controller. Affected units include product catalog numbers PT-000409, PT-000428, PT-000429, and all serial numbers/Controller lots.

Brand
Insulet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Charging Port
Look for melting, discoloring, or deformation in the Omnipod 5 Controller's charging port.
Use Backup Insulin Plan
If the controller fails to charge, switch to your backup insulin plan as instructed by your healthcare provider.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Domestic distribution nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 30 days after the firm started it.

Nov 14, 2022Firm started the recall
Dec 7, 2022FDA classified it Class II
Dec 14, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/59376-insulet-omnipod-5-controller-charging-port-melting-risk">Insulet Omnipod 5 Controller Charging Port Melting Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0423-2023 (November 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0423-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.