Sensors bound for destruction reached pharmacies — a recall with no shipping records
Lots of Dexcom continuous glucose monitoring sensors set aside for destruction were stolen during that process and sold on to pharmacies and distributors. With no shipping records, distribution was traced through app usage data.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firmDexcom, Inc.
- ReasonCertain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
- DistributionDexcom does not have distribution records for this product due to its unauthorized release. However Dexcom is able to identify sensor session starts for the affected lots through the Dexcom G7 CGM App...
- Recall initiated2026-05-27
Key points
- The product is the Dexcom G7 Continuous Glucose Monitoring System, US retail sensor and transmitter one-pack, model STP-AT-012.
- Lots set aside as scrap for destruction were stolen during that process and later sold to pharmacies and distributors by Pharmsource, LLC.
- Lot 1725204004 was not properly sterilized and carries an increased risk of skin infection if used.
- Lot 1725069002 carries an increased risk of absent readings or inaccuracy, including a missed hyperglycemic event or an incorrect treatment decision.
- With no shipping records available, distribution was established from app usage data identifying sensor session starts.
1Reading what Class II means, through eight records
Every FDA enforcement record carries a classification. **Class I covers a reasonable probability of serious injury or death. Class II covers a probability of temporary or medically reversible health consequences, or a remote probability of serious ones. This series puts one question to eight records: why was this not placed in the most serious class?**
2Class II is the majority of the record
Four in five records are Class II. Recalls are not reserved for what is likely to cause serious harm; most turn on a judgment that something could go wrong within a range that can be put right. What that judgment consists of is the subject here.
3An unusual route, but the class follows the outcome
What sets this record apart is how the product reached the market. Sensors due for destruction were stolen during that process and sold on through a third party to pharmacies and distributors.
Being stolen goods did not make the classification heavier. What the class looks at is what can happen when the product is used, not the route by which it arrived.
4Why each lot had been set aside
- 1Lot 1725204004Not properly sterilized, carrying an increased risk of skin infection if used
- 2Lot 1725069002An increased risk of no readings, or of inaccuracy carrying the potential for a missed hyperglycemic event or an incorrect treatment decision
- 3A further risk to bothThe storage and handling they underwent in distribution is unknown
- 4Where they wentApp usage data identified session starts for lot 1725069002 in the United States and 23 further countries and territories, Japan among them
Skin infection and inaccurate readings both sit within what medical intervention can put right, and that is why the class is II. The record nonetheless notes that injury here can include medical intervention to prevent permanent injury or impairment, which is close to the upper edge of the class.
Why it matters
A recall classification turns on what can happen when the product is used; however irregular the route to market, the route itself does not make the class heavier. What the absence of shipping records changes is the practice of the recall: with the manufacturer unable to say who holds the product, distribution has to be inferred through another channel entirely, in this case the usage data the device itself produces.
FAQ
Why is it Class II when the goods were stolen?
Why are there no shipping records?
How far did it travel?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2574-2026