Beta Bionics, Inc. recalls iLet Bionic Pancreas
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
iLet Bionic Pancreas1 code
- BB1001
Lot / code information
Software versions 1.4.3, and 1.4.2
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1996-2026
- FDA 510(k) clearance · K252770The device's official FDA premarket clearance record
- FDA device classification · QFGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5730The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Beta Bionics, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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