Home / Recalls / Dexcom, Inc. / Z-1944-2025

Z-1944-2025 Class I Ongoing

Recalled by Dexcom, Inc. — San Diego, CA

FDA device recall Z-1944-2025 was initiated by Dexcom, Inc. on May 12, 2025 and is designated Class I. 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 audib… The recall status is ongoing. Affected quantity: 602,445 units.

Recall Details

Product Type: Devices
Report Date: June 25, 2025
Initiation Date: May 12, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 602,445 units

Product Description

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)

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.

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.

Code Information

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

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