Recall Z-1946-2025— Dexcom, Inc.
Class I · Ongoing
Class I FDA medical device recall by Dexcom, Inc., initiated 2025-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2). Reason: 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..
- Recalling firm
- Dexcom, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-05-12
- Firm location
- San Diego, CA, United States
Product description
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.