Beta Bionics, Inc.
Beta Bionics, Inc. appears in FDA public data with 3 recalls, 6 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1996-2026, Class II) was initiated on March 12, 2026. Its most recent 510(k) clearance was granted on April 30, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 6
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1996-2026 | Class II | iLet Bionic Pancreas, REF: BB1001 | March 12, 2026 |
| Z-2513-2026 | Class II | iLet Bionic Pancreas, REF: BB1001 | September 23, 2025 |
| Z-1809-2026 | Class II | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software | August 13, 2025 |