CLASS I Device recall · Reported 23 Nov 2022 · FDA Enforcement Report
18239: ASM Omnipod Dash PDM, insulin delivery system recalled by Insulet
Insulet is recalling 18239: ASM Omnipod Dash PDM, insulin delivery system, distributed nationwide in the US. The recall was initiated on 17 Oct 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0154-2023
- FDA event ID
- 90987
- Recalling firm
- Insulet, Acton, MA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Oct 2022
- FDA classified
- 15 Nov 2022
- Reported
- 23 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 17 Oct 2022 | Recall initiated by company | |
| 15 Nov 2022 | Classified by FDA | +29 days |
| 23 Nov 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.
Where it was distributed
Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
Questions about this recall
Why was it recalled?
The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.
Which lots are affected?
Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots
Where was it sold?
Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Insulet
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |
| Device | CLASS I | Omnipod DASH Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |
| Device | CLASS I | Omnipod 5 Pods recalled by Insulet | Insulet | Packaging Defects | Nationwide |
| Device | CLASS I | Omnipod 5 Pods recalled by Insulet | Insulet | Packaging Defects | Nationwide |
| Device | CLASS II | The failure occurs if a user on the Omnipod 5 iOS recalled by Insulet | Insulet | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |