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U.S. Department of Health and Human Services

Class 2 Device Recall iLet ACE Pump, iLet Dosing Decision Software

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 Class 2 Device Recall iLet ACE Pump, iLet Dosing Decision Softwaresee related information
Date Initiated by FirmAugust 13, 2025
Date PostedApril 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1809-2026
Recall Event ID 98528
510(K)NumberK231485 K232224 
Product Classification Alternate controller enabled insulin infusion pump - Product Code QFG
ProductiLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Code Information ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
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		it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.
FDA Determined
Cause 2		Software design
ActionOn March 12, 2026 Beta Bionics issued a Urgent Medical Device Correction - Expansion/Update via Email to notify new consignees and previous consignees. Initial notification was issued on August 13, 2025. Beta Bionics ask consignees to take the following actions: 1. Download or update your iLet app on your phone. 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 acknowledgment survey https://sprw.io/stt-6HnQU or scan the QR code. This survey helps us monitor the effectiveness of the recall action.
Quantity in Commerce15 units
DistributionUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MA, MD, ME, MI, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY AND WASHINGTON DC.
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
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