iLet Bionic Pancreas
Beta Bionics, Inc. · Insulin pumps
No linked recall recordsLatest source check Oct 8, 2026
Loading MedWatcher information…
Loading MedWatcher information…
Devices and connected systems that deliver insulin, including pumps used in automated insulin delivery systems.
7 tracked devices · 21 recall records
Beta Bionics, Inc. · Insulin pumps
No linked recall recordsLatest source check Oct 8, 2026
Medtronic MiniMed, Inc. · Insulin pumps
No linked recall recordsLatest source check Aug 17, 2026
Medtronic MiniMed, Inc. · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
Insulet Corporation · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
Insulet Corporation · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
Tandem Diabetes Care, Inc. · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
Tandem Diabetes Care, Inc. · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
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…
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…
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…
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.…
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…
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs,…
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin…
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those…
Manufacturers are listed because their devices appear in monitored sources. Listing does not imply endorsement or partnership.