The Recall Desk

Manufacturer

Beta Bionics, Inc.

3 recalls in our database name Beta Bionics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
1
Most recent
2026-06-24

Of the 3 recalls from Beta Bionics, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-2513-2026·2026-06-24

    iLet Bionic Pancreas pumps may become stuck on the lock screen

    The iLet Bionic Pancreas is being recalled because a screen unlock failure can leave the user stuck on the Lock Screen, unable to change the cartridge or announce a meal.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-1996-2026·2026-05-06

    iLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings

    Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2026·2026-04-22

    iLet Ace insulin pump lock screens can be bypassed by users

    iLet Ace Pump Kits are being recalled because active status bar icons on the lock and passcode screens allow those screens to be bypassed, permitting unauthorized access.

    Product
    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

BETA BIONICS, INC.

Official website

Source: Wikidata (Q137697244), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.