iLet Ace Pump Kit recall
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Why was iLet Ace Pump Kit recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
- Product
- iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
- Recalling firm
- Beta Bionics, Inc.
- Quantity
- 15 units
- Distribution
- US 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.
- Recall date
- April 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)