FDA Medical devices recall ·
iLet Ace Pump Kit recall
- Recall number
- Z-1809-2026
- Date
- (initiated August 13, 2025)
- Company / brand
- Beta Bionics, Inc.
11 Hughes, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 15 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.
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.
States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Idaho Illinois Indiana Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Montana North Carolina Nebraska New Hampshire New Jersey Nevada New York Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina Tennessee Texas Utah Virginia Washington Wisconsin Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1809-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.