Device and safety alerts families should see first.
When FDA or manufacturers publish CGM, pump, insulin, or related device notices, they appear here from the live Type1Cure safety feed — ahead of general news.
Medtronic MiniMed, Inc. · Jul 22, 2026
Medtronic MiniMed, Inc.: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
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...
Open official noticeMedtronic MiniMed, Inc. · Jul 7, 2026
Medtronic MiniMed, Inc.: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
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...
Open official noticeInsulet Corporation · Jun 29, 2026
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...
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...
Open official noticeInsulet Corporation · Jun 29, 2026
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...
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...
Open official noticeInsulet Corporation · Jun 29, 2026
Insulet Corporation: 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...
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...
Open official noticeA Safety · Jun 29, 2026
A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes
RECRUITING, PHASE3. Interventions: VX-880. Locations: Duarte, California, United States | San Francisco, California, United States | Miami, Florida, United States. This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.
Open official noticeDexcom, Inc. · Jun 23, 2026
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...
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...
Open official noticeDexcom, Inc. · May 10, 2026
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...
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...
Open official noticeDexcom, Inc. · May 10, 2026
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...
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...
Open official noticeDexcom, Inc. · May 10, 2026
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...
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...
Open official noticeNorth American Rescue LLC. · Apr 28, 2026
North American Rescue LLC.: AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and...
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in ap... Action: On 3/27/2026, correction notices were emailed to customers asking them to take the following actions: For Health Care Profession...
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