Recall Z-1996-2026— Beta Bionics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beta Bionics, Inc., initiated 2026-03-12. It names one FDA 510(k) clearance: K252770. 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..
- Recalling firm
- Beta Bionics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-12
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.