FDAFDA recall Z-2513-2026 · Jun 24, 2026
Beta Bionics, Inc.: iLet Bionic Pancreas recall
Recall found
Product
iLet Bionic Pancreas, REF: BB1001
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)
- 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
- Recalling firm
- Beta Bionics, Inc., Irvine, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2025-09-23
Source: openFDA enforcement record Z-2513-2026 · search recall number Z-2513-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.