--- title: "Beta Bionics, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Beta Bionics, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/beta-bionics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Beta Bionics, Inc. recall records **3** reported ongoing 3 records in this archive. Latest source date Mar 12, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Mar 12, 2026 FDA device enforcement ### [iLet Bionic Pancreas, REF: BB1001](https://isitonrecall.com/recall/fda-device-z-1996-2026-ilet-bionic-pancreas-ref-bb1001/) 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... Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA. [Official source for iLet Bionic Pancreas, REF: BB1001](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1996-2026%22) Sep 23, 2025 FDA device enforcement ### [iLet Bionic Pancreas, REF: BB1001](https://isitonrecall.com/recall/fda-device-z-2513-2026-ilet-bionic-pancreas-ref-bb1001/) The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs,... Class II Reported ongoing Distribution: US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA, GA, MI, VT, TN, IL, IN, KS, MA, LA, MS, NC, CT, MN, VA, OK, AR, AZ, MO, MT, RI, DC, NM, OR, ID, NV, A... [Official source for iLet Bionic Pancreas, REF: BB1001](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2513-2026%22) Aug 13, 2025 FDA device enforcement ### [iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software](https://isitonrecall.com/recall/fda-device-z-1809-2026-ilet-ace-pump-kit-ref-bb1001-ilet-dosing-decision-software/) it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those... Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, LA, MA, MD, ME, MI, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR,... [Official source for iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1809-2026%22) ## Reasons in these listed records - 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/suspensi... - The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remain... - it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those ... These examples come from this result page and are not a ranking of every recall reason. ## Checking Beta Bionics, Inc. ### Is there a recall on beta bionics, inc. right now? This archive contains 3 records, including 3 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Beta Bionics, Inc.](https://isitonrecall.com/check/?q=Beta%20Bionics%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)