Omnipod 5 (pump)

The Omnipod 5 removes the most visible burden of pump therapy — the tubing — by putting the reservoir, cannula and even the control algorithm into a small waterproof Pod worn directly on the body.¹ For many people that form factor is the single biggest quality-of-life upgrade a pump can offer.

Form factor: a tubeless patch, not a tubed pump. There is no tubing and no separate insulin line — the Pod is a self-contained patch that sticks to the skin and is fully waterproof, rated IP28 for up to 25 feet (about 7.6 m) for 60 minutes, so you can shower and swim without disconnecting.¹² Insulin is delivered through a small flexible cannula inserted automatically when the Pod is first activated, rather than by a hand-pushed infusion set.²

Reservoir and wear. Each Pod holds up to 200 units of U-100 rapid-acting insulin and must be primed with at least 85 units to start.¹² It is worn for up to three days (72 hours) and is then replaced as a whole single-use unit — there is no durable pump body to recharge or refill.¹ It is compatible with NovoLog/NovoRapid, Humalog, Admelog and Kirsty (an insulin aspart).¹

Occlusion detection and reliability. Like all Insulet Pods, it monitors for blockages and sounds a hazard alarm if it detects an occlusion, prompting you to deactivate and change the Pod.² The platform has a large real-world track record: an analysis of 69,902 US users found a median time-in-range of 68.8% at the lowest (110 mg/dL [6.1 mmol/L]) glucose target, with very little time below 70 mg/dL (3.9 mmol/L).³ As with any patch pump, individual Pods can occasionally fail or occlude early, and a single failed infusion site can lead to a high or, rarely, ketoacidosis.⁴

Recalls you should know about (2026). Omnipod Pods were the subject of two separate Class I FDA recalls in 2026 — Class I is the FDA's most serious category, used when a defect can cause serious injury or death. They are different defects, both lot-specific, and neither means every Pod is affected.

• Internal tubing tear (classified Class I on 29 April 2026). Pods from certain lots could develop a tear in the Pod's internal tubing, so insulin leaks inside the Pod instead of reaching the body. Insulet wrote to affected customers on 12 March 2026 and the FDA issued an Early Alert on 18 March. This one affected Omnipod 5 Pods. As of 17 April 2026, Insulet had reported 29 serious injuries and no deaths.⁵
• Cannula tear above the skin (classified Class I on 2 July 2026). A manufacturing fault can leave a small tear in the cannula — the soft tube that goes into you — just above the skin, so insulin leaks outside the body rather than being delivered. Insulet began a voluntary Medical Device Correction on 26 May 2026 covering specific lots of Omnipod 5, Omnipod DASH and Omnipod (Eros) Pods: roughly 7 million Pods, about 8.5% of 2025 global production, of which Insulet estimates around 60% had already been used or had expired. The FDA issued an Early Alert on 4 June and classified it Class I on 2 July 2026. As of 20 May 2026, Insulet had reported 24 serious injuries — high blood glucose including hospitalisation and diabetic ketoacidosis — and no deaths.⁶⁷

The part that matters most for day-to-day safety: in both cases the under-delivery may happen without triggering any alarm. You might notice wetness or the smell of insulin at the site, but you might notice nothing at all — which is exactly why unexplained highs on Omnipod deserve a Pod change and a ketone check rather than a correction bolus alone, and why device alerts should not be your only line of defence. Both recalls are lot-specific: check your Pod lot numbers with Insulet (which is replacing affected Pods free of charge) rather than assuming your supply is or is not involved, and talk to your clinic before changing anything about your therapy.⁶⁷ Neither FDA notice lists Omnipod GO among the affected devices, though the notices define scope by lot rather than affirmatively clearing other products.

Which CGMs and algorithms it works with. Uniquely, the SmartAdjust algorithm runs on the Pod itself, not on the phone: every five minutes it reads the CGM value and trend, predicts glucose 60 minutes ahead, and increases, decreases or pauses delivery toward a customizable target.⁸¹ It integrates with Dexcom G6, Dexcom G7 and the FreeStyle Libre 2 Plus and Libre 3 Plus sensors.⁹ It is a closed commercial system — it does not work with DIY/open-source loops, and its on-Pod algorithm is ranked separately as an AID system on this site.⁸

Phone bolusing. Omnipod 5 was the first tubeless AID with full smartphone control: you can bolus and manage settings directly from a compatible iPhone or Android phone using the Omnipod 5 app and its SmartBolus calculator, with no separate handheld required (a dedicated Insulet Controller is still offered).⁸⁹

Access and cost by region. It is FDA-cleared in the US for people aged 2 and older with type 1 diabetes (originally ages 6+ in January 2022, later expanded), and it is uniquely available through the pharmacy channel rather than only durable-medical-equipment suppliers.⁸¹⁰ In the UK it launched in June 2023 and is available on NHS frameworks, rolling out to people who qualify under the NICE hybrid-closed-loop program; it is also marketed across the EU.¹⁰¹¹ The ongoing cost of single-use Pods is the trade-off for having no expensive durable hardware.

The enhanced algorithm has now shipped. The FDA cleared an updated Omnipod 5 algorithm in December 2025, and on 3 June 2026 Insulet announced its US rollout — an over-the-air software update delivered through the Omnipod 5 Controller or phone app, reaching new and existing US users rather than requiring new hardware.¹²¹³ It adds a 100 mg/dL (5.6 mmol/L) target glucose option, giving six settings from 100 to 150 mg/dL (5.6–8.3 mmol/L), and improves alarm handling so people stay in Automated Mode with fewer interruptions, including during prolonged high glucose events.¹³ That narrows the gap with the most aggressive competing systems, which have long allowed tighter targets. The same announcement confirmed US compatibility with Abbott's FreeStyle Libre 3 Plus sensor.¹³

What's still coming. Insulet has extended Omnipod 5 to adults with type 2 diabetes, where an early trial cut HbA1c by 1.3 percentage points, and continues to widen CGM and phone compatibility.¹⁴⁹

References

1. Insulet (Omnipod). Simplify Life with Omnipod 5 — product overview (tubeless waterproof Pod, IP28 to 25 ft/60 min, up to 200 U U-100 insulin, ~72 h wear, on-Pod SmartAdjust, compatible insulins). https://www.omnipod.com/what-is-omnipod/omnipod-5 ↩ ↩² ↩³ ↩⁴ ↩⁵ ↩⁶

2. Insulet (Omnipod). Important Safety Information (waterproof IP28 rating, cannula delivery, occlusion detection and hazard alarm, ~85 U minimum fill). https://www.omnipod.com/safety ↩ ↩² ↩³ ↩⁴

3. Forlenza GP, DeSalvo DJ, Aleppo G, et al. Real-World Evidence of Omnipod 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes. Diabetes Technology & Therapeutics (2024); 26(8):514–525. PMID 38375861. https://doi.org/10.1089/dia.2023.0578 ↩

4. Brown SA, Forlenza GP, Bode BW, et al. Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes. Diabetes Care (2021); 44(7):1630–1640. According to PubMed. https://pmc.ncbi.nlm.nih.gov/articles/PMC8323171/ (DOI) ↩

5. US Food & Drug Administration. Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods (customer letter Mar 12, 2026; Early Alert Mar 18, 2026; classified as a Class I recall Apr 29, 2026; tear in the Pod's internal tubing; 29 serious injuries and no deaths as of Apr 17, 2026). https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-recall-insulet-removes-certain-omnipod-5-pods ↩

6. US Food & Drug Administration. Insulin Pump Recall: Insulet Removes Omnipod Pods (Early Alert Jun 4, 2026; classified as a Class I recall Jul 2, 2026; cannula tear just above the skin; "may happen without triggering any alert"; affects Omnipod 5, Omnipod DASH and Omnipod (Eros) Pods from specific lots; 24 serious injuries and no deaths as of May 20, 2026). https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-recall-insulet-removes-omnipod-pods ↩ ↩²

7. Insulet Corporation. Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod Pods in the U.S. and Affected International Markets (May 26, 2026; ~7 million Pods, ~8.5% of 2025 global production, ~60% already used or expired; leak "may be difficult to detect and go unnoticed"; free replacement of affected lots). https://investor.insulet.com/news/news-details/2026/Insulet-Initiates-Voluntary-Medical-Device-Correction-for-Certain-Omnipod-Pods-in-the-U-S--and-Affected-International-Markets/default.aspx ↩ ↩²

8. Insulet Corporation. FDA Clearance of its Omnipod 5 Automated Insulin Delivery System — First Tubeless System with Smartphone Control (Jan 28, 2022; SmartAdjust runs on the Pod, 5-minute cycle, 60-minute prediction, Dexcom G6 integration, smartphone control, ages 6+ at clearance). https://s201.q4cdn.com/452214269/files/doc_news/2022/01/28/Insulet-Announces-FDA-Clearance-of-its-Omnipod®-5-Automated-Insulin-Delivery-System-First-Tubeless-System-with-Smartphone-Control.pdf ↩ ↩² ↩³ ↩⁴

9. Insulet (Omnipod). Omnipod 5 Smartphone & CGM Device Compatibility (Dexcom G6, Dexcom G7, FreeStyle Libre 2 Plus and Libre 3 Plus; iPhone and Android app control). https://www.omnipod.com/current-podders/resources/omnipod-5/device-compatibility ↩ ↩² ↩³

10. Breakthrough T1D UK. Omnipod 5 becomes the latest hybrid closed loop system available in the UK (UK launch June 2023; ages 2+; available on NHS frameworks). https://breakthrought1d.org.uk/news/omnipod-5-becomes-the-latest-hybrid-closed-loop-system-available-in-the-uk/ ↩ ↩²

11. Diabetes UK. Omnipod 5 can now connect with the Dexcom G7 CGM (UK availability and NHS access via the NICE hybrid-closed-loop rollout). https://www.diabetes.org.uk/about-us/news-and-views/omnipod-5-first-tubeless-hybrid-closed-loop-system-now-available-uk ↩

12. Kelly J (Healio). FDA clears updated algorithm with lower target glucose setting for Omnipod 5 (Dec 8, 2025; targets as low as 100 mg/dL, six target options 100–150 mg/dL, fewer interruptions during highs). https://www.healio.com/news/endocrinology/20251208/fda-clears-updated-algorithm-with-lower-target-glucose-setting-for-omnipod-5 ↩

13. Insulet Corporation. Insulet Announces U.S. Rollout of Enhanced Omnipod 5 Algorithm and Expands Compatibility with Abbott's FreeStyle Libre 3 Plus Sensor (Jun 3, 2026; FDA 510(k) clearance December 2025; new 100 mg/dL target option, six settings 100–150 mg/dL; fewer interruptions during prolonged highs; over-the-air update via Controller or app; US Libre 3 Plus compatibility). https://investor.insulet.com/news/news-details/2026/Insulet-Announces-U-S--Rollout-of-Enhanced-Omnipod-5-Algorithm-and-Expands-Compatibility-with-Abbotts-FreeStyle-Libre-3-Plus-Sensor/default.aspx ↩ ↩² ↩³

14. Davis GM, Peters AL, Bode BW, et al. Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes: From Injections to Hybrid Closed-Loop Therapy. Diabetes Care (2023); 46(4):742–750. According to PubMed. https://pmc.ncbi.nlm.nih.gov/articles/PMC10090930/ (DOI) ↩