FDA recall, , Moderate risk
Beta Bionics iLet Bionic Pancreas
This can lead to hyperglycemia.
Summary by Recall Canary from the FDA notice
What happened
Beta Bionics, Inc., of Irvine, California, recalled the iLet Bionic Pancreas, REF: BB1001, because in version 3.3.6 of the iLet ACE Pump firmware and all previous releases, 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. The company began the recall on September 23, 2025, and the FDA added it to its Enforcement Report on June 18, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the reference number. Check the FDA notice for any lot or serial number limits.
iLet Bionic Pancreas
- Reference number
- BB1001
- Affected units
- iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)
Recall details
- Company began the recall
- Sold in
- 50 states and DC
- Alabama
- Alaska
- Arizona
- Arkansas
- California
- Colorado
- Connecticut
- Delaware
- District of Columbia
- Florida
- Georgia
- Hawaii
- Idaho
- Illinois
- Indiana
- Iowa
- Kansas
- Kentucky
- Louisiana
- Maine
- Maryland
- Massachusetts
- Michigan
- Minnesota
- Mississippi
- Missouri
- Montana
- Nebraska
- Nevada
- New Hampshire
- New Jersey
- New Mexico
- New York
- North Carolina
- North Dakota
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Vermont
- Virginia
- Washington
- West Virginia
- Wisconsin
- Wyoming
- Company
- Beta Bionics, Inc.Irvine, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98517
- Recall number
- Z-2513-2026
All recalls from Beta Bionics, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
