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 Trials Act T0
Environmental Determinants of Type 1 Diabetes Risk ClinicalTrials.gov / Sep 22, 2026 / Official recruiting registry
RECRUITING. Locations: Changsha, Hunan, China. To analyze the environmental risk factors for type 1 diabetes in China.
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
Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus ClinicalTrials.gov / Sep 7, 2026 / Official recruiting registry
RECRUITING, PHASE2. Interventions: Rezpegaldesleukin, Placebo. Locations: San Francisco, California, United States | Aurora, Colorado, United States | New Haven, Connecticut, United States. This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezp...
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
INNODIA Family & Friends Early-Stage T1D Detection Protocol ClinicalTrials.gov / Aug 23, 2026 / Official recruiting registry
RECRUITING. Locations: Vienna, Austria | Leuven, Belgium | Prague, Czechia. The purpose of INNODIA DETECT is to identify people who are at increased risk of developing T1D. Investigators are doing this by testing for markers in the blood (autoantibodies) that tell them an individuals risk of getting T1D in the future. What is Type 1 Diabetes (T1D)? T1D is a serious disease where the blood glucose (sugar) level is too high because the body cannot make a ho...
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.: 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 Safety Act T0
Medtronic MiniMed, Inc.: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 openFDA device recalls / Jul 7, 2026 / FDA recall database
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis... Action: On 5/27/2026, field safety notices were emailed to customers who were asked to do the following: 1) Update insulin pump software...
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
Insulet Corporation: Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6... openFDA device recalls / Jun 29, 2026 / FDA recall database
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of in... Action: Insulet initially issued a press release on 05/26/2026 along with an "Urgent: Medical Device Correction" on the same day. Consig...
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
Insulet Corporation: Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I... openFDA device recalls / Jun 29, 2026 / FDA recall database
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of in... Action: Insulet initially issued a press release on 05/26/2026 along with an "Urgent: Medical Device Correction" on the same day. Consig...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source