Dexcom, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1946-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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)

Product Classification:

Class I

Date Initiated: May 12, 2025

Date Posted: June 25, 2025

Recall Number: Z-1946-2025

Event ID: 96743

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.

Status: Ongoing

Product Quantity: 38,127 units

Code Information:

All Lots/ UDI: STK-DO-006 -00386270003188 STK-DO-013 -00386270002327 STK-DO-103-00386270002969 STK-DO-109 -00386270002792

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated