Z-2513-2026Class II

iLet Bionic Pancreas, REF: BB1001

Name: Z-2513-2026 iLet Bionic Pancreas, REF: BB1001
Creator: Beta Bionics, Inc.
Published: 2025-09-23
License: https://open.fda.gov/license/

Beta Bionics, Inc. / initiated 2025-09-23 / Open, Classified / root cause: software

FDA source

Beta Bionics, Inc. began a recall of iLet Bionic Pancreas, REF: BB1001 on 2025-09-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2513-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-23
Posted: 2026-06-18
Recalling firm: Beta Bionics, Inc.
Product: iLet Bionic Pancreas, REF: BB1001
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
Reason for recall: 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 tag: software
FDA 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 in commerce: 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
Product codes and lots: iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2513-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2513-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-18

Product code QFG

K252770Class IIiLet ACE PumpBeta Bionics, Inc. / cleared 2025-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)