Summary
The FDA issued a Class II for iLet Bionic Pancreas, REF: BB1001 by Beta Bionics, Inc.. Reason: 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 the.
Details
Source
Device Recall
External ID
Z-1996-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
iLet Bionic Pancreas, REF: BB1001
Lot/Code Info: Software versions 1.4.3, and 1.4.2
Quantity Affected: 1,080
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.
Distribution
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-12
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beta Bionics, Inc. has 8 FDA actions in our database, including 3 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beta Bionics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beta Bionics, Inc. have FDA actions?
Beta Bionics, Inc. has 8 FDA actions in our database, including 3 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1996-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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