Class II recallOngoing

iLet Bionic Pancreas recall — FDA event 98475

FDA · FDA event 98475 · Posted Apr 29, 2026

Published Apr 29, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists iLet Bionic Pancreas by Beta Bionics, Inc..

Products affected by FDA event 98475
Model	Description	Lot / serial range	Manufactured	Status
Z-1996-2026	Z-1996-2026	Software versions 1.4.3, and 1.4.2	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

Mar 12, 2026
Recall initiated
Date recorded by the FDA.
Apr 29, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98475
Published: Apr 29, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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iLet Bionic Pancreas recall — FDA event 98475

FDA · FDA event 98475 · Posted Apr 29, 2026

Published Apr 29, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

This FDA record lists iLet Bionic Pancreas by Beta Bionics, Inc..

Products affected by FDA event 98475
Model	Description	Lot / serial range	Manufactured	Status
Z-1996-2026	Z-1996-2026	Software versions 1.4.3, and 1.4.2	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.

Units affected

See official FDA record

iLet Bionic Pancreas recall — FDA event 98475

Follow iLet Bionic Pancreas

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

iLet Bionic Pancreas recall — FDA event 98475

Follow iLet Bionic Pancreas

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline