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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98475

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 12, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Beta Bionics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

iLet Bionic Pancreas, REF: BB1001

Z-1996-2026
Recall number
Z-1996-2026
Initiated
March 12, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Beta Bionics, Inc.
Quantity
1,080

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software versions 1.4.2, and 1.4.3 issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.

Code information

Software versions 1.4.3, and 1.4.2

Distribution pattern

US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.

Field note

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