Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver
Medical device recall Z-1338-2016. 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
- 19,586 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 (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.
19,586, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Receiver Kit Number: STK-PR-001 STK-CR-001 STR-PR-001 STK-PR-PNK STK-CR-PNK STR-PR-PNK STK-PR-BLU STK-CR-BLU STR-PR-BLU Lot Number: 5197950 5198382 5199018 5200680 5201286 5201394 5202064 5202065 5202311 5202779 5203297 5204321 5197967…
Every code shown here, 1,996 characters
Receiver Kit Number: STK-PR-001 STK-CR-001 STR-PR-001 STK-PR-PNK STK-CR-PNK STR-PR-PNK STK-PR-BLU STK-CR-BLU STR-PR-BLU Lot Number: 5197950 5198382 5199018 5200680 5201286 5201394 5202064 5202065 5202311 5202779 5203297 5204321 5197967 5198434 5198901 5199013 5199213 5200586 5201276 5201288 5201391 5202073 5202074 5202420 5202801 5203631 5204325 5205014 5197968 5198378 5198896 5201272 5201376 5202084 5202085 5202432 5202881 5203322 5204328 5197951 5197952 5197953 5197954 5198371 5198372 5198373 5198381 5198488 5198489 5198490 5198491 5198511 5198711 5199020 5199021 5199206 5199208 5201231 5201232 5201283 5201284 5201388 5201389 5201995 5201998 5202066 5202067 5202068 5202069 5202070 5202071 5202072 5202308 5202417 5202421 5202780 5202877 5203320 5203472 5204962 5208005 5209676 5209677 5197955 5197956 5197957 5198374 5198409 5198418 5198419 5198435 5198436 5198437 5198450 5198613 5198710 5198898 5198902 5198998 5199000 5199017 5199215 5199216 5199217 5200587 5200652 5200653 5200654 5200655 5200656 5200657 5201233 5201234 5201243 5201247 5201248 5201249 5201277 5201278 5201279 5201287 5201386 5201393 5202075 5202076 5202077 5202078 5202079 5202080 5202081 5202082 5202307 5202412 5202418 5202799 5202896 5203291 5203316 5205000 5207992 5210398 5210399 5197958 5197959 5197960 5197961 5198375 5198376 5198377 5198386 5198387 5198427 5198447 5198712 5198742 5198743 5198744 5198900 5198999 5199019 5200588 5200589 5200590 5200591 5201235 5201236 5201237 5201238 5201239 5201273 5201274 5201997 5202086 5202093 5202094 5202095 5202096 5202423 5202428 5202785 5202802 5202878 5203286 5203328 5204311 5209680 5209681 5197910 5198379 5198899 5200522 5201285 5201387 5201398 5202312 5202424 5202897 5205010 5206620 5208805 5210020 5210067 5210394 5197966 5199016 5199214 5200583 5201250 5201275 5201289 5201385 5201390 5202083 5203292 5204317 5205020 5206583 5208006 5208818 5210021 5210036 5210471 5198380 5198886 5200584 5201271 5202017 5202115 5202415 5202789 5203289 5204340 5205001…
FDA’s list runs to 2,043 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 2,043 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.