Compare the complete identifiers. Name similarity alone is not a confirmed match.
iLet Bionic Pancreas, REF: BB1001
| Product or model | Codes and lots | Quantity | Recall number |
|---|---|---|---|
| iLet Bionic Pancreas, REF: BB1001 | Software versions 1.4.3, and 1.4.2 | 1,080 | Z-1996-2026 |
The agency's statement is shown without a site-authored severity score.
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.
Agency classification: Class II
Only instructions associated with this recall event qualify as an action.
Consumer action is not available in the associated official record. The site does not infer or generate a replacement.
The linked agency record controls if any information differs.
Official scope
US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.
No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.
