Z-1809-2026Class II

iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

Name: Z-1809-2026 iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Creator: Beta Bionics, Inc.
Published: 2025-08-13
License: https://open.fda.gov/license/

Beta Bionics, Inc. / initiated 2025-08-13 / Open, Classified / root cause: software

FDA source

Beta Bionics, Inc. began a recall of iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software on 2025-08-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1809-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-13
Posted: 2026-04-10
Recalling firm: Beta Bionics, Inc.
Product: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
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.
Root cause tag: software
FDA root cause: Software design
Action: On 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 commerce: 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.
Product codes and lots: ILet Ace Pumps containing software version BOM000036 Rev C (version 1.4.2) or older.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1809-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1809-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-10

Product code QFG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)