FDA Medical Device Recalls (openFDA)
Beta Bionics, Inc.: iLet Bionic Pancreas, REF: BB1001
- Recall number
- Z-2513-2026
- Recalling firm
- Beta Bionics, Inc.
- Product
- iLet Bionic Pancreas, REF: BB1001
- Status
- Open, Classified
- Initiated
- 2025-09-23
- Posted
- 2026-06-18
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- On 3/12/2026, recall notices were mailed and emailed to customers who were informed of the following: On September 23, 2025, Beta Bionics, Inc. issued an Urgent Medical Device Correction notification to customers informing them of the lock screen software issue and software upgrade. These problems are resolved in newer host software versions (3.3.7 and up). Please check your software version and update your software as soon as possible. Update your software 1. Download or update your iLet app on your phone. Need help! Read the iLet App User Guide. 2. Log into your iLet app. 3. Position your iLet next to your phone with the app open. 4. Go to app settings on the iLet app and follow the on-screen instructions to update to the latest firmware. 5. Complete the acknowledgement survey at https://sprw.io/stt-3tkjI or If you have any questions, please call the firm's Customer Care at 1-855-745-3800 option 1.
- Quantity
- 4580
- Distribution
- US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, AK, ND, DE, WV, WY, SD, UT, AL
- Lot, serial or model codes
- iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)
- 510(k) numbers
- ["K252770"]
- PMA numbers
- not on file
- Product code
- QFG
- Firm FEI
- 3019004087
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28