Beta Bionics recalls

Beta Bionics has 3 recalls on record with the FDA and USDA, the earliest in 2026 and the latest reported on 24 Jun 2026. 3 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls3since 2026

Last 12 months3reported

Class I00% of total

Ongoing3latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 1Apr 1 1 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why beta bionics is recalled

Device Malfunction267%
Lead & Heavy Metals133%

Product types

Other Medical Devices267%
Medical Software133%

By year

20263100%

Ongoing beta bionics recalls

3 active

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
6 May 2026Device	CLASS II	iLet Bionic Pancreas recalled by Beta Bionics	Beta Bionics	Device Malfunction	Nationwide
22 Apr 2026Device	CLASS II	iLet Ace Pump Kit recalled by Beta Bionics	Beta Bionics	Device Malfunction	Nationwide

All beta bionics recalls, newest first

3 total

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
6 May 2026Device	CLASS II	iLet Bionic Pancreas recalled by Beta Bionics	Beta Bionics	Device Malfunction	Nationwide
22 Apr 2026Device	CLASS II	iLet Ace Pump Kit recalled by Beta Bionics	Beta Bionics	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.