Beta Bionics, Inc. recalls 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…
Read the official notice →- Date
- 2026-06-24
- Country
- United States
- Brand
- Beta Bionics
- Product
- iLet Bionic Pancreas, REF: BB1001
- Classification
- Class II
- Units
- US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Beta Bionics recalls
- 2026-05-06
USBeta Bionics, Inc. recalls 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…
FDA · DeviceBeta Bionics, Inc.US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.Official notice →- 2026-04-22
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Beta Bionics, Inc. recalls 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,…
FDA · DeviceBeta Bionics, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →
Other drugs & medical recalls in the United States
- 2026-06-24
- US
Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180…
Due to unsealed portions of pouches.
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Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The…
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or…
FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice → - US
BD SWITZERLAND SARL recalls BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication…
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FDA · DeviceBD SWITZERLAND SARLU.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI,…Official notice → - US
Staar Surgical AG recalls Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is…
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
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Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU…
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FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the countries of AE, BB, BM, BS,…Official notice → - US
MITO RED LIGHT INC recalls Mito Red Light, Super Mobile
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
FDA · DeviceMITO RED LIGHT INCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →