Insulet Recalls OmniPod Insulin Management System Due to Needle Deployment Failure
Insulet Corporation is recalling 5,179 boxes of OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it poses a reasonable probability of serious adverse health consequences.
Plain-English summary
Insulet Corporation is recalling 5,179 boxes of the OmniPod Insulin Management System (OUS), Catalog Number 14810. The recall involves specific lot codes: L41908, L41910, and F41935. The product is intended for the subcutaneous delivery of insulin for the management of diabetes mellitus and for the quantitative measurement of glucose in fresh whole capillary blood.
The recall was initiated because the pod's needle mechanism may fail to deploy or there may be a delay in the deployment of the needle mechanism. This defect could prevent the proper administration of insulin or the measurement of glucose.
The affected products were distributed worldwide, including in the United States, Switzerland, Germany, and Israel. Consumers who have these specific lot codes should stop using the product and contact Insulet Corporation for further instructions.
The recalled product
- Product
- OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for…
- Manufacturer
- Insulet Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Codes: L41908
- L41910
- F41935
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Insulet Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Insulet Corporation
See all →- SevereOmnipod Eros Pod Insulin Delivery Failure Risk
FDA (Devices) · 2026-07-08
- SevereOmnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
FDA (Devices) · 2026-07-08
- CriticalOmnipod DASH Pod insulin pump affected by external cannula damage
FDA (Devices) · 2026-07-08
- SevereOmnipod 5 insulin pods from 49 lots have torn internal cannulas
FDA (Devices) · 2026-04-22
- HighOmnipod 5 app recalled because magnifying a field duplicates typed digits
FDA (Devices) · 2025-10-22
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- SevereInsulet Recalls OmniPod Insulin Devices Due to Deployment Failures
FDA (Devices) · 2015-09-16
- SevereInsulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures
FDA (Devices) · 2015-09-16
- SevereInsulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error
FDA (Devices) · 2020-06-10
- HighInsulet Recalls Omnipod DASH Insulin Systems Due to Communication Interruption
FDA (Devices) · 2019-11-13
- SevereOmnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
FDA (Devices) · 2026-07-08
- ModerateInsulet Recalls OmniPod Insulin Starter Kits Due to Mislabeling
FDA (Devices) · 2013-11-13