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FDA-Device2026-04-22Class IIPROCESSING DEFECT

Beta Bionics iLet Ace Pump Kit recalled for security bypass allowing unauthorized insulin access

Beta Bionics
OTHERNationwide distribution

Update your Beta Bionics iLet Ace Pump immediately

Certain versions of the iLet Ace Pump software (1.3.7, 1.4.2, and 1.4.3) have a security flaw that allows someone to bypass the Lock Screen and Limited Access Passcode Screen by pressing icons in the status bar. This could let an unauthorized person make false meal announcements or stop insulin delivery, risking severe low blood sugar.

  • Check your iLet Ace Pump software version immediately
  • If your version is 1.4.2 or older, contact Beta Bionics for a software update
  • Do not leave your pump unattended or accessible to others until updated
  • Watch for signs of severe low blood sugar (confusion, shakiness, sweating)
Hazard

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.

Sold states
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.
Affected count
15 units
Manufactured in
11 Hughes, N/A, Irvine, CA, United States
Products
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1809-2026

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