Beta Bionics, Inc. — FDA Compliance Timeline

FDA action counts

Enforcement history

On 2026-04-22, Argus HQ recorded a FDA recall for Beta Bionics, Inc., rated "high" severity in Argus HQ's classification: Beta Bionics, Inc. — Class II recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-05-06, Argus HQ recorded a FDA recall for Beta Bionics, Inc., rated "high" severity in Argus HQ's classification: Beta Bionics, Inc. — Class II recall: iLet Bionic Pancreas, REF: BB1001 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-24, Argus HQ recorded a FDA recall for Beta Bionics, Inc., rated "high" severity in Argus HQ's classification: Beta Bionics, Inc. — Class II recall: iLet Bionic Pancreas, REF: BB1001 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Beta Bionics, Inc. has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Beta Bionics, Inc. has 3 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event.

Frequently asked questions

Has Beta Bionics, Inc. had product recalls?

Yes, 3 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Beta Bionics, Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Beta Bionics, Inc. had?

Argus HQ has recorded 3 FDA events for Beta Bionics, Inc.: 0 warning letters, 3 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Beta Bionics, Inc.?

The most recent FDA event Argus HQ has on file for Beta Bionics, Inc. is dated 2026-06-24, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Related enforcement actions

• Beta Bionics, Inc. — Class II recall: iLet Bionic Pancreas, REF: BB1001 →
• Beta Bionics, Inc. — Class II recall: iLet Bionic Pancreas, REF: BB1001 →
• Beta Bionics, Inc. — Class II recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software →

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