Beta Bionics, Inc. recalls
Every recall we track for Beta Bionics, Inc. — 3 in all, from 2025–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
3 recalls since 2017.
All FDA recall records for Beta Bionics, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 2 | 0 | 0 | 2 |
| 2026 (to date) | 0 | 1 | 0 | 0 | 1 |
What to do if you have a recalled Beta Bionics, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Beta Bionics, Inc. recalls
3 shown- Use cautionMedical device
Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001
Beta Bionics recalls iLet Bionic Pancreas software versions 1.4.2 and 1.4.3 due to potential delayed glucose readings causing unsafe insulin dosing. Affected users may experience severe high or low blood sugar levels.
Beta BionicsMar 12, 2026 - Use cautionMedical device
Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001
Beta Bionics recalls iLet ACE Pump firmware version 3.3.6 and earlier due to screen unlock failure causing inability to change insulin cartridges or meal announcements, risking hyperglycemia.
Beta BionicsSep 23, 2025 - Use cautionMedical device
Beta Bionics, Inc. recalls iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Beta Bionics recalls iLet Ace Pump Kit software versions 1.3.7, 1.4.2, and 1.4.3 due to potential unauthorized access causing severe hypoglycemia. Affected users should check their software version.
Beta BionicsAug 13, 2025
Beta Bionics, Inc. recall questions
How many recalls has Beta Bionics, Inc. had?
3 recalls from Beta Bionics, Inc. are on record with U.S. safety agencies, from 2025–2026.
What is the most recent Beta Bionics, Inc. recall?
Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001, dated Mar 12, 2026. Every Beta Bionics, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Beta Bionics, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Beta Bionics, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.