FDA and Dexcom have apparently announced a recall of CGM receivers. This is NOT the CGM device you attach to yourself (sensor, transmitter, combo), just the small handheld phone like receiver. The recall affects the G6, G7, ONE, and ONE+ receivers. See the article on CNET at: https://www.cnet.com/health/medical/these-continuous-glucose-monitors-have-been-recalled-due-to-faulty-speakers-what-you-need-to-do-to-stay-safe/ or at the FDA site: Continuous Glucose Monitor Receiver Recall: Dexcom, Inc. Removes Certain Dexcom G6, G7, ONE, and ONE+ Receivers Due to Speaker Malfunction That May Cause Missed Alerts for Dangerous Blood Sugar Levels | FDA. There’s a link part way down in the CNET article that leads to the FDA site which lists the device UDI/Model # as well as Lot/Sn. Even if you don’t use your’s its worth checking as it may serve as your emergency back-up.
FYI: The recall may be confusing to some of us (like my simple mind). My receiver has one of the indicated reference number (STK-AT-012) and Part Numbers (MT26403-0), but my serial number, according to the Dexcom website, is NOT part of the recall. If you question whether your’s is part of the recall, you can check it at Check Dexcom Receiver | Dexcom. If you have the original box, your number should be located on a label similar to the pic below, with your serial number to the right of a box with “SN” with a box around it. Alternately, you can look at a label on the back of your receiver for a similar SN number (the website has a picture of where its supposed to be located). On the website, enter your SN number twice (2nd time for confirmation for us fat fingered types) and then you’ll get a response whether your receiver is included. Please, don’t enter the number in the picture, (it’s mine) enter your own off your box or receiver.
Might be nice if anyone with a recalled receiver would post what Dexcom says to do with it and how to obtain a new one.
Just curious, does anyone use these? I remember getting one way back in the day, but with the phone app and the link to the Tslim, I don’t even think I can hook it up (I recall that there may be only two devices you can pair to). This is a slight hijack of this thread, so @TomH apologies …
Just wondering …
@bostrav59 I received one with my initial order of sensors. It was probably included by my Endo because it was an initial order, but I didn’t see it because of e-script direct to the pharmacy. I take it with me as a backup, but use my iPhone and apps for Dexcom and DIY Trio otherwise. I don’t I’ve ever charged it up or used it to date and still have it in the original box with docs, etc.!
My brother uses one still, because it takes the “medical device” Bluetooth slot. My pump takes that slot for me, and you can’t connect two “medical devices” (just a medical device and phone), so I haven’t used it in years.
Anyone in the US on Medicare; the Medicare rules require us to have one and to use it at unspecified intervals (not all the time). I use mine to sync up to the G7 after I’ve connected from my app (xDrip+) and also if the app cannot connect (failed sensor) so that I have the log of the failure. I connect it, power it down and stick it back in the box, legal requirements met (IMNSHO).
I originally got it on the ACA a little over a year ago because I hoped it would allow me to monitor two sensors at once during the overlap. Nope; the stupid iReceiver insists on disabling the old G7 before it connects to the new one!
Anyway, that original receiver failed after 1 year and 20 days; nothing to do with the speaker, it just went into a reboot loop every time it was started. Dexcom said it was out of warranty (the ones on private insurance only last 12 months) so I got a new one on Medicare and this one lasts three years!
Now if I was on private US insurance any longer I’d be complaining about private insurance customers getting production line rejects while old, near death, fogeys like me get the primo kit.
BTW, if I actually had one with a dead speaker I might leave it switched on all the time. Sounds (or not) like a major improvement to me.
Medicare does not require you to use or receive a receiver to use the cgm from Dexcom. If you use a pump the transmitter is of no use at all. Medicare acknowledges this.
Is there an official website document that shows that? Many of us on Medicare got the receiver from our medical equipment supplier and were notified that Medicare at that time would not cover Dexcoms if you used a phone to monitor.
Medicare pays for dexcom CGMs if you use a phone, a pump, or a receiver. There is NO requirement that you use a receiver.
To the contrary, here’s the word from the official source, CMS.
“CGM devices that solely display results on a smartphone and do not have a stand-alone receiver or integration into an insulin infusion pump do not meet the definition of DME and will be denied as non-covered (no benefit).”
That’s in paragraph 4 of the Glucose Monitor Policy Article in the Medicare Coverage Database, revision date 2/18/25. It’s available at
Strictly, the CGM must be integrated with your pump, or you must use the receiver. You don’t have to use the receiver and/or pump exclusively, but you are required to use it sometimes. It’s up to you to decide how frequently “sometimes” is. The point is that the G7 sensor can’t be legally characterized as Durable Medical Equipment because it doesn’t last long enough. The way it can be covered is as disposable supplies for something else that is covered as Durable Medical Equipment. And a smartphone can’t legally be covered as DME, which is why you need to use the receiver or pump with the G7 at least part of the time.
@bkh Thanks for the posting of a source document coming from CMS! Unless CMS has docs that conflict, that would seem to settle the discussion. My understanding has been the reasoning boils done to DME status and the only way to do it is when the functioning portion is disposable is with a long term component. I believe CMS will have issues in the future with the definition, but for now it seems settled.
Inconceivable! That in our government the left hand might not know what the right hand is doing? Simply inconceivable.
And…. “Never get involved in a land war in Asia!”
I just realized that I don’t even have a current receiver!
So you are not required to us the receiver, period.
You are absolutely correct. If you pair a G7 sensor with your t:slim X2 pump, that fully satisfies the requirement.
It’s only a rule infraction if you only ever use a phone app. In that case, Medicare has the right to deny reimbursement and perhaps even the right to claw back previous reimbursements. I’ve not heard of them conducting audits to enforce this rule.
It’s Medicare policy 52464, summarised:
Under the current regulations a device which uses the “receiver” slot fulfills the same function for MediCare. I can’t remember if the conclusions of an extended investigation with @spdif on TUD got posted but the rules, while they certainly change, basically require something to occupy the receiver slot.
The rules are on cms.gov and the rules that are applicable is that for “non-adjunctive CGMs”, in rule 33822 and the related rules:
The relevant text is available in one form in the policy article:
Coverage of a CGM system supply allowance (code A4238 or A4239) is available for CGM systems when the beneficiary uses a stand-alone receiver or insulin infusion pump classified as DME to display glucose data. In addition, Medicare coverage is available for a CGM system supply allowance if a non-DME device (watch, smartphone, tablet, laptop computer, etc.) is used in conjunction with the durable CGM receiver (code E2102 or E2103). The following are examples of this provision:
- Medicare coverage of a CGM supply allowance is available when a beneficiary uses a durable CGM receiver to display their glucose data and also transmits that data to a caregiver through a smart phone or other non-DME receiver.
- Medicare coverage of a CGM system supply allowance is available when a beneficiary uses a durable CGM receiver on some days to review their glucose data but uses a non-DME device on other days.
If a beneficiary never uses a DME receiver or insulin infusion pump to display CGM glucose data, the supply allowance is not covered by Medicare.
So, translated, a Part B pump (not the Omnipod) is equivalent to a “DME receiver”, but it must be DME. So those of us who use the Omnipod or MDI must have a receiver. So what that says is that if you use the O5 you must also use the Dexcom receiver, although I believe that is impossible.
I checked my receiver SN, found it was part of the recall, and called Dexcom at 1-844-478-1600 (there is apparently no online option to request a replacement). I had been on hold with Dexcom for over 95 minutes listening to the same song when I started typing this post to ask if anyone had had any success getting their receiver replaced. Then Dexcom answered the phone, checked my receiver serial number, verified my personal information, and put me on hold again. After two minutes, the Dexcom representative returned to the call, telling me I would be mailed a new receiver within 5 to 7 business days, and that I am to return my old receiver in the enclosed pre-addressed envelope via FedEx. The total interaction was less than five minutes, but I was on the phone for an hour and 40 minutes so I guess they’re bombarded right now.
PS I do find my receiver necessary and keep it on me at all times. I just had to rely on it yesterday when I had a meeting for probate at the courthouse where no cell phones are allowed. In addition, I’ve been in locations such as rural areas and a cruise ship where the cellphone Bluetooth does not work for whatever reason and my receiver is the only way to get blood sugars besides a finger-stick, which none of us with Dexcom want to do anymore. I also have a sleep app I love that I have been using for 10 years that overrides all notifications so my receiver is the only way I get notifications while I’m sleeping.
I use the G6 receiver when I am at home. Why? Because unlocking the phone to acknowledge an alarm is harder than acknowledging it on the receiver. The phone has more buttons to push for unlocking!
For this reason I don’t have Dex running on my phone during the day. But I turn it on the phone at night so I can use closed loop.
But when I go out, I leave the receiver at home and only bring my phone, so I don’t have to carry an extra piece of stuff.