Dexcom G4 PLATINUM Receiver with Share Receiver
Medical device recall Z-1337-2016. Published in FDA’s Enforcement Report on Apr 20, 2016.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 20, 2016. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 53,106 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
53,106, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Receiver Kit Number: STK-DR-001 STK-RR-001 STR-DR-001 STK-DR-PNK STK-RR-PNK STR-DR-PNK STK-DR-BLU STK-RR-BLU STR-DR-BLU Lot Number: 5197900 5197901 5197902 5197903 5197904 5197905 5197906 5197907 5197908 5197909 5197962 5197964 5197965…
Every code shown here, 1,996 characters
Receiver Kit Number: STK-DR-001 STK-RR-001 STR-DR-001 STK-DR-PNK STK-RR-PNK STR-DR-PNK STK-DR-BLU STK-RR-BLU STR-DR-BLU Lot Number: 5197900 5197901 5197902 5197903 5197904 5197905 5197906 5197907 5197908 5197909 5197962 5197964 5197965 5198423 5198424 5198425 5198432 5198433 5198446 5198448 5198455 5198456 5198457 5198463 5198493 5198495 5198496 5198497 5198505 5198506 5198557 5198558 5198559 5198560 5198561 5198567 5198607 5198608 5198894 5198895 5199491 5200521 5200548 5200612 5200682 5200688 5200833 5200834 5201244 5201245 5201282 5201292 5201378 5201380 5201418 5201419 5201420 5201422 5201423 5202036 5202037 5202038 5202039 5202040 5202041 5202042 5202043 5202044 5202045 5202046 5202047 5202048 5202049 5202050 5202051 5202052 5202247 5202301 5202304 5202410 5202411 5202426 5202776 5202777 5202786 5202787 5202796 5202797 5202866 5202869 5202873 5202879 5203264 5203296 5203305 5203315 5203323 5203324 5203503 5204322 5204943 5204949 5205009 5205058 5206616 5206626 5206726 5207988 5208004 5208038 5208514 5208516 5208520 5208809 5208888 5209615 5209667 5209671 5210272 5197928 5197929 5197930 5197931 5197932 5197969 5197983 5198394 5198395 5198414 5198415 5198417 5198426 5198428 5198429 5198449 5198893 5199015 5199034 5199035 5199211 5199212 5200520 5200549 5200611 5200686 5200828 5201241 5201242 5201246 5201259 5201260 5201261 5201406 5201407 5201409 5201410 5201411 5202026 5202028 5202029 5202030 5202031 5202032 5202033 5202034 5202111 5202116 5202129 5202305 5202422 5202732 5202781 5202792 5202865 5202870 5202872 5203284 5203321 5203325 5203473 5204315 5204318 5204948 5205016 5206631 5208010 5208379 5208521 5208889 5209672 5209673 5210392 5197944 5197972 5197974 5197978 5197979 5197980 5198483 5198508 5198509 5198510 5198903 5199014 5199161 5199463 5199464 5199466 5200552 5200553 5200613 5200681 5201240 5201357 5201358 5201359 5201400 5201401 5201402 5201403 5201999 5202000 5202001 5202002 5202018 5202019 5202020 5202021 5202022 5202108 5202109 5202160 5202303…
FDA’s list runs to 3,307 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 23, 2016.
- FDA classified it on Apr 11, 2016.
- FDA’s Enforcement Report published it on Apr 20, 2016.
- FDA terminated it on Aug 11, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Dexcom Inc, of San Diego, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,307 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.