CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report

iLet Bionic Pancreas recalled by Beta Bionics

Beta Bionics is recalling iLet Bionic Pancreas, distributed nationwide in the US. The recall was initiated on 12 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware versions 1.4.3, and 1.4.2

Quantity recalled1,080

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1996-2026
FDA event ID: 98475
Recalling firm: Beta Bionics, Irvine, CA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Mar 2026
FDA classified: 29 Apr 2026
Reported: 6 May 2026
Type: Voluntary: Firm initiated
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Mar 2026	Recall initiated by company
29 Apr 2026	Classified by FDA	+48 days
6 May 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

iLet Bionic Pancreas, REF: BB1001

Where it was distributed

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

Nationwide Alabama Florida Georgia Michigan Ohio Pennsylvania Tennessee Texas

Questions about this recall

Is iLet Bionic Pancreas recalled?

Yes. Beta Bionics recalled iLet Bionic Pancreas on 12 Mar 2026. The recall is Class II and its status is Ongoing. Recall number Z-1996-2026.

Why was it recalled?

Which lots are affected?

Software versions 1.4.3, and 1.4.2

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Beta Bionics

All 3

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	iLet Bionic Pancreas recalled by Beta Bionics	Beta Bionics	Lead & Heavy Metals	51 states
22 Apr 2026Device	CLASS II	iLet Ace Pump Kit recalled by Beta Bionics	Beta Bionics	Device Malfunction	Nationwide

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