Omnipod 5 recall notice - check your lot number

https://www.businesswire.com/news/home/20260312976912/en/Insulet-Initiates-Voluntary-Medical-Device-Correction-for-Certain-Omnipod-5-Pods-in-the-U.S.

“Insulet identified that certain Pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the Pod instead of being fully infused into the body as intended.“

Enter your lot # here to see if it is included in the recall: Check Your Pod Lot | Omnipod

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Mine was clear. It was odd I had three boxes bought at two times 3 months apart but with the same lot numbers. Freaky man.

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I wonder if the same issue could affect the Dash production line; I’ve been having problems, on and off, for three or four months now. I’ve deduced a “site issue” resulting in low or no effectiveness of boluses (hence high BG) but it could be the described issue.

Someone else mentioned the same issue recently in one of the Medicare related threads.

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I asked them if we could see the tear through visual inspection, but no one responded (they didn’t seem to know).

Crap, John. Maybe it is. Have you tried to bolus via syringe and got similar results?

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I checked lots for my Om5 pods and am all clear! Thanks @mohe0001 for the heads up.

I’m curious if any Omnipod users received a notification from Insulet…phone call, text, email? (I didn’t). Seems like a serious enough defect that they should have contacted us all.

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If it’s a site problem changing the site will fix it. Tears in clear tubing are very difficult to see, but big (ish) blobs of insulin are not. The tear would presumably be worse on larger boluses, because these generate more pressure (though maybe not enough to be significant). My current pod is showing what I would expect to be the signs; rage boluses don’t work but standard AAPS corrections do.

So that could be a site issue or it could be a 'pod issue. The difference is where the insulin ends up; if it’s inside the pod (but outside the syringe) then it certainly should not be there. It’s not visible through the inspection hatch, though I’ll try to remember to check that when I take the pod off.(I’ve got 26 hours to go but maybe I’ll change it at 72 hours, not 80 like I normally do.)

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I’m suspicious.

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I received a email last Thursday.

Omnipods emails always get sent to my junk folder for some reason even though I a mark them as safe. I think they might send out things from different addresses???

It’s from - The Omnipod Team

Subject line- URGENT: Medical Device Correction

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My (Dash) problem seems to have been a site issue; I had a bleeder. When I took the pod off I had a blood clot on my skin, the site bleed significantly, and the Dash pod capillary leaked insulin (about 1IU) implying it had been blocked at the site and, indeed, it contained a small amount of blood (half way down the exposed part).

I don’t understand why I got the symptoms I did get, maybe the site was just clogged up with half clotted blood. The pod itself looked clean, it had a completely clean inspection window. I might take it apart just to see but in these circumstances I don’t think I could separate out a pod problem from the site issue.

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Good. Ok. I’m glad that’s resolved. I occasionally see failure associated with a ‘bleeder.’ But not often. I can sometimes feel the wet insulin leak out at a bad site, but not 100% of the time. I bet the cannula got a little blocked with clotted blood or something.

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I received an email

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Never received an email from them…This morning I received this text message:

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:sweat_smile: It’s so kind of them to alert you first thing in the morning at 6AM.

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It turns out my email address on “podder central” was an old expired one…now updated/fixed. That is why they did not email me.

I’ve been bugging Insulet tech support lately about the new pods and software for the Omnipod 5. Every time I call and ask “when will it be available?” they are clueless and eventually check with the higher ups and come back with an answer of: “we don’t know, you’ll get an email some day.” The Dec. ‘25 press release about the improvements says pods and app both need to be updated to use the improved algorithm.

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My Dash needs an update, allegedly. You know I called tech support last week because I was getting errors from refusing to update, and they didn’t have my pump registered. It made me wonder if they just keep upgrading my pump model into infinity. I’ll have to update to 5 soon.

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