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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96743

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 12, 2025
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Dexcom, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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

Z-1943-2025
Recall number
Z-1943-2025
Initiated
May 12, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Dexcom, Inc.
Quantity
36,824 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All Lots/ UDI: STK-FM-001 - 00386270003232 & STK-FR-001 - 00386270003225

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.

device · product 2 of 4

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)

Z-1944-2025
Recall number
Z-1944-2025
Initiated
May 12, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Dexcom, Inc.
Quantity
602,445 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

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

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.

device · product 3 of 4

Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)

Z-1945-2025
Recall number
Z-1945-2025
Initiated
May 12, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Dexcom, Inc.
Quantity
26,291 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All Lots/ UDI: STK-D7-013 - 00386270003812; STK-D7-014 - 00386270003843; STK-D7-103 - 00386270003836

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.

device · product 4 of 4

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)

Z-1946-2025
Recall number
Z-1946-2025
Initiated
May 12, 2025
Classification
Class I
Status
Ongoing
Recalling firm
Dexcom, Inc.
Quantity
38,127 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

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.