FDA Medical devices recall ·
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0)… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1944-2025
- Date
- (initiated May 12, 2025)
- Company / brand
- Dexcom, Inc.
6340 Sequence Dr, San Diego, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 602,445 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3)
Why was it recalled?
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All Lots/ UDI: STK-AT-011 - 00386270002198 STK-AT-012 -00386270002518 STK-AT-013 - 00386270002525 STK-GT-001 - 00386270004291 STK-GT-008 - 00386270004260 STK-GT-013 - 00386270002273 STK-GT-019 - 04595986293080 STK-GT-100 - 00386270002020 STK-GT-109 - 00386270002129 STK-GT-113 - 00386270003638
Distribution
worldwide distribution - US Nationwide and the countries of Andorra, Argentina Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, New Zealand, Norway, Oman, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1944-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.