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,…
Read the official notice →- Date
- 2026-04-22
- Country
- United States
- Brand
- Beta Bionics
- Product
- iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-06-24
USBeta 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…
FDA · DeviceBeta Bionics, Inc.US: WI, HI, OH, ME, CO, NJ, NE, KY, SC, CA, TX, NH, NY, WA, PA, MD, FL, IA,…Official notice →- 2026-05-06
- US
Beta 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 →
Other drugs & medical recalls in the United States
- 2026-04-22
- US
Wilson-Cook Medical Inc. recalls Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
FDA · DeviceWilson-Cook Medical Inc.Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalls Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the…
- US
Linkbio Corp. recalls LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
FDA · DeviceLinkbio Corp.US Nationwide distribution in the state of Alabama, Florida, and Kansas.Official notice → - US
Remel, Inc recalls Yeastone Broth, 11ML, 10/BOX YY3462
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
FDA · DeviceRemel, IncWorldwide distribution - US Nationwide and the countries of Canada, Vietnam,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to…
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
B Braun Medical Inc recalls B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
FDA · DeviceB Braun Medical IncWorldwide distribution - US Nationwide and the country of Canada.Official notice →