FDA Device recall Z-1996-2026
iLet Bionic Pancreas, REF: BB1001
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of iLet Bionic Pancreas, REF: BB1001 by Beta Bionics, citing 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, le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1996-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-12 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Beta Bionics |
| Distribution | US |
Product
iLet Bionic Pancreas, REF: BB1001
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 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.
Identifiers
| code_info | Software versions 1.4.3, and 1.4.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1996-2026%22
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