Recall Z-1943-2025— Dexcom, Inc.

Name: FDA recall Z-1943-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-12

Class I · Ongoing

Class I FDA medical device recall by Dexcom, Inc., initiated 2025-05-12. It names one FDA 510(k) clearance: K223931. Product: Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1). 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

510(k) clearances named in this recall

1 on FDA's record

K223931 — Dexcom G6 Continuous Glucose Monitoring (CGM) SystemDexcom, Inc.·cleared 2023-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)

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.