Beta Bionics, Inc.
Beta Bionics, Inc. has 3 FDA enforcement events on this register (3 product records) between 2025 and 2026: 3 device; the busiest year was 2025 with 2.
0% of its events are Class I; the most common class is Class II (3). 3 events are listed as ongoing; the recalling firm's address is in CA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 12 Mar 2026 | iLet Bionic Pancreas, REF: BB1001 | Device | Class II | 1 | Ongoing |
| 23 Sep 2025 | iLet Bionic Pancreas, REF: BB1001 | Device | Class II | 1 | Ongoing |
| 13 Aug 2025 | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software | Device | Class II | 1 | Ongoing |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Beta Bionics, Inc. had?
3 enforcement events (3 product records) on this register, 2025–2026: 3 device.
Are any Beta Bionics, Inc. recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are Beta Bionics, Inc. recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.