iLet Bionic Pancreas
Beta Bionics, Inc. · Insulin pumps
No recall records foundLast checked Aug 17, 2026
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Reviewed V1 category
Devices and connected systems that deliver insulin, including pumps used in automated insulin delivery systems.
FDA product codes and descriptions are normalized into this consumer-facing category. Raw regulator terminology remains source evidence rather than separate public category pages.
7 tracked devices · 18 recall records
Beta Bionics, Inc. · Insulin pumps
No recall records foundLast checked Aug 17, 2026
Medtronic MiniMed, Inc. · Insulin pumps
No recall records foundLast checked Aug 17, 2026
Medtronic MiniMed, Inc. · Insulin pumps
Active recall recordLast checked Oct 8, 2026
Insulet Corporation · Insulin pumps
Active recall recordLast checked Oct 8, 2026
Insulet Corporation · Insulin pumps
Active recall recordLast checked Oct 8, 2026
Tandem Diabetes Care, Inc. · Insulin pumps
Active recall recordLast checked Oct 8, 2026
Tandem Diabetes Care, Inc. · Insulin pumps
Active recall recordLast checked Oct 8, 2026
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…
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to…
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…
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion…
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in…
Manufacturers are listed because their devices appear in monitored sources. Listing does not imply endorsement or partnership.