Z-1996-2026Class II

iLet Bionic Pancreas, REF: BB1001

Name: Z-1996-2026 iLet Bionic Pancreas, REF: BB1001
Creator: Beta Bionics, Inc.
Published: 2026-03-12
License: https://open.fda.gov/license/

Beta Bionics, Inc. / initiated 2026-03-12 / Open, Classified / root cause: software

FDA source

Beta Bionics, Inc. began a recall of iLet Bionic Pancreas, REF: BB1001 on 2026-03-12. FDA classified it as Class II and gives the reason as "insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses...". 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-1996-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-12
Posted: 2026-04-29
Recalling firm: Beta Bionics, Inc.
Product: iLet Bionic Pancreas, REF: BB1001
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
Reason for recall: insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
Root cause tag: software
FDA root cause: Software change control
Action: On 3/12/2026, correction notices were emailed to customers who were asked to do the following: Update device software to host software 1.4.4 and up. Update your software 1. Download or update your iLet app on your phone. Read the iLet App User Guide: https://www.betabionics.com/wp-content/uploads/LA000056_F-iLet-Mobile-App-User-Guide.pdf 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. -Distributors are asked to provide patient contact information so the firm can provide the correction notice to these patients. - Complete the acknowledgment survey https://sprw.io/stt-6HnQU If you have any questions, please call the firm's Customer Care at 1-855-745-3800 option 1.
Quantity in commerce: 1,080
Distribution: US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Product codes and lots: Software versions 1.4.3, and 1.4.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1996-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1996-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code QFG

K252770Class IIiLet ACE PumpBeta Bionics, Inc. / cleared 2025-09-29

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)