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Beta Bionics, Inc. FDA Recalls
3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| iLet Bionic Pancreas, REF: BB1001Class IIMar 12, 2026insulin pump software versions 1.4.2, and 1.4.3 issue with D |
| iLet Bionic Pancreas, REF: BB1001Class IISep 23, 2025The reason for the recall is: it was found in version 3.3.6 |
| iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision SoftwareClass IIAug 13, 2025it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the L |