# FDA recall Z-1996-2026

> **Beta Bionics, Inc.** · Class II · device recall initiated 2026-03-12.

## Product

iLet Bionic Pancreas, REF: BB1001

## 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.

## Key facts

- **Recall number:** Z-1996-2026
- **Recalling firm:** Beta Bionics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-03-12
- **Report date:** 2026-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1996-2026

## Citation

> AI Analytics. FDA recall Z-1996-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1996-2026. Source: US FDA. Licensed CC0.

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