Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall iLet ACE Pump

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall iLet ACE Pumpsee related information
Date Initiated by FirmSeptember 23, 2025
Date PostedJune 18, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2513-2026
Recall Event ID 98517
510(K)NumberK252770 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
ProductiLet Bionic Pancreas, REF: BB1001
Code Information iLet ACE Pump firmware BOM000072 Rev C (version 3.3.6) and BOM000072 Rev B (version 3.3.4)
FEI Number 3019004087
Recalling Firm/
Manufacturer		 Beta Bionics, Inc.
11 Hughes
Irvine CA 92618-1902
For Additional Information ContactKaren Hynes
855-745-3800
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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 Commerce4580
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QFG
-
-