Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
USOmnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Recalling Firm: Insulet Corporation
Motivo del Retiro / Peligro
TranslatedDue 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 delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
Descripción del Producto e Identificación
TranslatedOmnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Additional Source Details
| Field | Value |
|---|---|
| City | Acton |
| State | MA |
| Event id | 98586 |
| Address 1 | 50 & 100 Nagog Park |
| Address 2 | N/A |
| Code info | Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7. UDI-DI: 10385083000527. Lot Codes: PH1U02252541, PH1U03282511, PH1U03282522, PH1U03312511, PH1U03312521, PH1U04012511, PH1U04012521, PH1U05052511, PH1U08162531, PH1U08182531, PH1U08182541, PH1U09242511, PH1U09242521, PH1U09242531, PH1U09252521, PH1U09252531, PH1U10152541, PH1U10162531, PH1U10162541, PH1U10172531, PH1U10172541, PH1U10182531, PH1U10182541, PH1U10202511, PH1U10202521, PH1U10202531, PH1U10202541, PH1U10212531, PH1U10212541, PH1U10222531, PH1U10222541, PH1U10232531, PH1U10232541, PH1U10242521, PH1U10242531, PH1U10242541. |
| Postal code | 01720-3440 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 1,240,115 units |
| Reason for recall | 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 delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260312 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260410 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
Revise otros productos en su hogar
Herramientas GratuitasSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Resumen
- Empresa ResponsableInsulet Corporation
- StatusOngoing
- Nivel de RiesgoClass I
- DistributionNationwide distribution.
📢 Compartir advertencia
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Insulet Corporation - Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 Check if your household is affected: https://therecallfile.com/es/recalls/omnipod-5-pods-model-catalog-number-pt-001662-asm-5pk-pod-strl-ops-g6g/FDA-Z-1797-2026
Unirse a la lista de alertas
Reciba alertas por correo electrónico cuando se publiquen retiros críticos.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Retiros Relacionados
UKField Safety Notices: 31 August to 4 September 2026
Field Safety Notices: 31 August to 4 September 2026
List of Field Safety Notices from 31 August to 4 September 2026....
AustraliaNutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables
Nutra-life Magnesium and Sleep Products and Musashi Pre Workout Chewables
Vitaco Health Australia Pty Ltd (Vitaco) is alerting customers that sucralose, an artificial sweetener, was used in 23 batches of Nutra-life and Musashi products rather than thaumatin, a natural sweet...
AustraliaAidacare Aspire Active Air 8 Pressure Care Air Mattress
Aidacare Aspire Active Air 8 Pressure Care Air Mattress
Aidacare Pty Ltd has updated the user manual for the Aspire Active Air 8 Pressure Care Mattress to add setup instructions and warnings about using the device in the presence of oxygen enriched environ...