Reported Jun 24, 2026 · Ongoing
iLet Bionic Pancreas, REF: BB1001
Beta Bionics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beta Bionics, Inc. · 11 Hughes · Irvine, CA · 92618-1902
Is this the product you have?
- iLet Bionic Pancreas
- REFBB1001
- Lot codes and dates
- iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)
- Amount recalled
- 4580
Where it was sold
Why it was recalled
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, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.
This product could cause temporary or reversible health problems — stop using it.
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