Safety Act T0
Tandem Diabetes Care, Inc.: Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1... openFDA device recalls / Oct 29, 2026 / FDA recall database
Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin flow obstruction is present. Investigation determined that increased friction within the drive module can reduce available motor power and, under certain conditions, cause motor speed to fall below the occlusion detecti... Action: On 9/23/2026, "URGENT MEDICAL DEVICE CORRECTION" recall and correction notices were emailed to customers who were asked to do th...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source Safety Act T0
Medtronic MiniMed, Inc.: Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: Th... openFDA device recalls / Oct 21, 2026 / FDA recall database
A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind user... Action: On 09/14/2026, customers were contacted via SMS, emailed or via an "URGENT MEDICAL DEVICE CORRECTION" Letter informing them that...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source Trials Act T0
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes ClinicalTrials.gov / Oct 15, 2026 / Official recruiting registry
RECRUITING, PHASE1, PHASE2. Interventions: Anti-thymocyte globulin (ATG), verapamil extended-release capsule, Adalimumab. Locations: Los Angeles, California, United States | San Francisco, California, United States | New Haven, Connecticut, United States. This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons a...
Why it matters: Recruiting status can change quickly. Families should review official eligibility, location, burden, and care-team fit before sharing health information.
Open original source Trials Act T0
SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes ClinicalTrials.gov / Oct 12, 2026 / Official recruiting registry
RECRUITING, PHASE2. Interventions: High Dose SAB-142, Low Dose SAB-142, Placebo. Locations: San Francisco, California, United States | San Jose, California, United States | Aurora, Colorado, United States. This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).
Why it matters: Recruiting status can change quickly. Families should review official eligibility, location, burden, and care-team fit before sharing health information.
Open original source Trials Act T0
Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes ClinicalTrials.gov / Oct 7, 2026 / Official recruiting registry
RECRUITING, NA. Interventions: Insulin Self-Management Know-Find-Solve Activity Book, Routine education. Locations: Istanbul, Turkey (Türkiye). Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children...
Why it matters: Recruiting status can change quickly. Families should review official eligibility, location, burden, and care-team fit before sharing health information.
Open original source Trials Act T0
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults ClinicalTrials.gov / Oct 7, 2026 / Official recruiting registry
RECRUITING, PHASE3. Interventions: Baricitinib, Placebo. Locations: Santa Barbara, California, United States | Tallahassee, Florida, United States | Iowa City, Iowa, United States. The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.
Why it matters: Recruiting status can change quickly. Families should review official eligibility, location, burden, and care-team fit before sharing health information.
Open original source Safety Act T0
Medtronic MiniMed, Inc.: Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller en... openFDA device recalls / Oct 4, 2026 / FDA recall database
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposur... Action: On 08/20/2026, Technical Support called affected customers to inform that, MiniMed identified an issue in which certain MiniMed...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source Safety Act T0
Tandem Diabetes Care, Inc.: Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.... openFDA device recalls / Sep 28, 2026 / FDA recall database
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P... Action: On 07/16/2026, an "URGENT MEDICAL DEVICE CORRECTION" communication was sent via certified mail to customers informing them that a...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source Safety Act T0
Medtronic MiniMed, Inc.: MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; openFDA device recalls / Aug 17, 2026 / FDA recall database
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Action: On 7/13/2026, field safety notices were sent to customers asking them to do the following: 1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. 2) Contact your Healthcare Professional (H...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source Safety Act T0
Medtronic MiniMed, Inc.: MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782; openFDA device recalls / Aug 17, 2026 / FDA recall database
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Action: On 7/13/2026, field safety notices were sent to customers asking them to do the following: 1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. 2) Contact your Healthcare Professional (H...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source Safety Act T0
Medtronic MiniMed, Inc.: MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW openFDA device recalls / Aug 17, 2026 / FDA recall database
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. Action: On 7/13/2026, field safety notices were sent to customers asking them to do the following: 1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. 2) Contact your Healthcare Professional (H...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source Safety Act T0
Medtronic MiniMed, Inc.: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) openFDA device recalls / Jul 22, 2026 / FDA recall database
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia. Action: On 6/16/2026 In-App Push Notifications were sent to customers entitled, Important Field Safety Corrective Action required on your MiniMed Go ap...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source