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 Trials Act T0
Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System ClinicalTrials.gov / Jul 1, 2026 / Official recruiting registry
RECRUITING, NA. Interventions: Omnipod 5 System, Omnipod 6 System. Locations: Los Angeles, California, United States | Santa Barbara, California, United States | Aurora, Colorado, United States. This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.
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
FDA device recall: 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
FDA device recall: 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 Safety Act T0
FDA device recall: Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420... 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
Dexcom, Inc.: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Produ... openFDA device recalls / Jun 23, 2026 / FDA recall database
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725... Action: On 05/26-27/2026, the firm issued a Press Release and sent an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" informing custome...
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
Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes ClinicalTrials.gov / Jun 11, 2026 / Official recruiting registry
RECRUITING. Locations: Aurora, Colorado, United States. This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.
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
Thrive With Type 1 Diabetes 2026 ClinicalTrials.gov / Jun 10, 2026 / Official recruiting registry
RECRUITING, NA. Interventions: TranS-C Intervention Arm, Attention Control Enhanced Usual Care (EUC) Arm. Locations: Atlanta, Georgia, United States | Atlanta, Georgia, United States. This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.
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
Dexcom, Inc.: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Produc... openFDA device recalls / May 10, 2026 / FDA recall database
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EG... Action: On 04/14/2026, the firm sent via the iOS App an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" communication informing custome...
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
Dexcom, Inc.: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Pr... openFDA device recalls / May 10, 2026 / FDA recall database
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EG... Action: On 04/14/2026, the firm sent via the iOS App an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" communication informing custome...
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
Dexcom, Inc.: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product... openFDA device recalls / May 10, 2026 / FDA recall database
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EG... Action: On 04/14/2026, the firm sent via the iOS App an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" communication informing custome...
Why it matters: Device and supply recalls can affect insulin delivery, glucose readings, replacement needs, and urgent family safety decisions.
Open original source