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Omnipod® insulin management system - omnipod®

Official notice

1 Jun 2026

CriticalHealth Canada

An official Health Canada notice concerns Omnipod® insulin management system - omnipod®. The defect is related to tears on the external (exposed) soft cannula. The defect is consistently located near the bottom housing window, with similar physical appearance and tear orientation across devices. The cannula tear may result in a compromised fluid path due to damage to the cannula, leading to potential reduced or interrupted insulin delivery. If insulin is not delivered properly, user may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated. To identify the impacted product and lot number, users will be asked to review the notification letter and follow the instructions: Discontinue use of any impacted pod immediately. If the pod the user is currently using, is from an affected lot, it is important that the user immediately changes the pod to resume insulin delivery. When changing the pod, confirm that the new pod is not from an affected lot. Published 2026-06-01.

What to do now

For further details on this recall, please refer to the manufacturer’s website at: https://www.omnipod.com/en-ca/fsn-5-26

Recall number

82140

Official notice

2026-06-01

The hazard

The defect is related to tears on the external (exposed) soft cannula. The defect is consistently located near the bottom housing window, with similar physical appearance and tear orientation across devices. The cannula tear may result in a compromised fluid path due to damage to the cannula, leading to potential reduced or interrupted insulin delivery. If insulin is not delivered properly, user may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated. To identify the impacted product and lot number, users will be asked to review the notification letter and follow the instructions: Discontinue use of any impacted pod immediately. If the pod the user is currently using, is from an affected lot, it is important that the user immediately changes the pod to resume insulin delivery. When changing the pod, confirm that the new pod is not from an affected lot.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

L72521, L72516, PH1U01222522, users

Skus

ZXR420, POD-ZXR425, POD-OMNI-I1-6729, POD-BLE-C1-520, POD-BLE-C1-529, POD-OMNI-I1-6720

Other

RA RA-82140

Model Numbers

ZXR420, POD-ZXR425, POD-OMNI-I1-6729, POD-BLE-C1-520, POD-BLE-C1-529, POD-OMNI-I1-6720

Recall Numbers

82140

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Affected products

Product 1

Lot or serial number - L72521, Model or catalogue number - ZXR420

Product 2

Lot or serial number - L72516, Model or catalogue number - POD-ZXR425

Product 3

Lot or serial number - PH1U01222522, Model or catalogue number - POD-OMNI-I1-6729

Product 4

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - POD-BLE-C1-520

Product 5

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - POD-BLE-C1-529

Product 6

Lot or serial number - PH1U01222522, Model or catalogue number - POD-OMNI-I1-6720

Risk / hazard

The defect is related to tears on the external (exposed) soft cannula. The defect is consistently located near the bottom housing window, with similar physical appearance and tear orientation across devices. The cannula tear may result in a compromised fluid path due to damage to the cannula, leading to potential reduced or interrupted insulin delivery. If insulin is not delivered properly, user may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated. To identify the impacted product and lot number, users will be asked to review the notification letter and follow the instructions: Discontinue use of any impacted pod immediately. If the pod the user is currently using, is from an affected lot, it is important that the user immediately changes the pod to resume insulin delivery. When changing the pod, confirm that the new pod is not from an affected lot.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Manufacturer

Not provided

Phone

Not provided

Brand: Insulet.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type I

App estimate

critical

Recall details

Recall number

82140

Classification

Type I

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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