Insulet (Nasdaq:PODD) today announced a voluntary medical device correction for specific lots of its Omnipod 5, Dash and Eros pods. The company identified a manufacturing issue through ongoing product monitoring that could result in insulin under-delivery with the affected current-generation Omnipod 5, previous-generation Omnipod Dash or the prior Omnipod Insulin Management System (Eros). Insulet said […]
Recalls
Dexcom says third party stole, sold scrapped G7 CGM lots
Dexcom (Nasdaq:DXCM) announced today that third parties stole and sold certain G7 continuous glucose monitor (CGM) lots designated as scrap. The company identified the lots — stolen during the destruction process — through ongoing quality and accounting reviews. At this moment, the company reports two G7 lots (1725204004 and 1725069002) as stolen, sold and used by some […]
Insulet issues warning on certain Omnipod 5 pumps due to manufacturing issue
Insulet (Nasdaq:PODD) today initiated a voluntary medical device correction for specific lots of Omnipod 5 insulin pump pods. Omnipod 5 — the world’s first available tubeless, wearable, automated insulin delivery system — is a patch-based pump system designed to proactively correct for glucose highs every five minutes and protect against lows with insulin dosing. Acton, […]
Beta Bionics receives FDA warning letter
Beta Bionics (Nasdaq:BBNX) recently disclosed the receipt of a warning letter from the FDA following an inspection. An FDA inspection of the company’s Irvine, California, facility from June 9, 2025, through June 26, 2025, led to the warning letter. In the letter, the FDA outlined deficiencies in the automated insulin delivery system maker’s response letters […]
Abbott initiates correction for FreeStyle Libre 3, Libre 3 Plus CGMs after reports of deaths
Abbott (NYSE:ABT) announced today that it issued a medical device correction for certain FreeStyle Libre 3 and Libre 3 Plus sensors in the U.S. This correction comes as a result of an issue that led to hundreds of severe adverse events, including seven deaths. Abbott — one of the largest diabetes tech companies in the world — […]
ICU Medical issues infusion pump software correction labeled serious by FDA
The FDA issued a notice labeling a recall of ICU Medical (Nasdaq: ICUI) infusion pumps as the most serious type of recall. This recall involves correcting certain devices. It does not require removing them from where they are used or sold. However, the FDA identified that the issue may cause serious injury or death if […]
Baxter issues correction for some Novum IQ infusion pumps
Baxter (NYSE:BAX) has issued a letter to affected customers recommending a correction for its Novum IQ infusion pump systems. The correction applies to all Novum IQ large volume pumps (LVP) and syringe pumps (SP). Baxter said users should consider alternate pumps if available for care involving high-risk medications and/or critical illness. However, customers can continue […]
Medtronic issues CGM app warning in Spain
The Spanish Agency for Medicines and Medical Devices (AEMPS) has received notice of potential accessibility issues with Medtronic CGM apps. Medtronic Diabetes — soon to be MiniMed after its planned separation from the medtech giant – contacted users of certain Samsung Galaxy A13 smartphone devices, as those are used as a Medtronic smart monitoring receiver with […]
Tandem Diabetes Care issues insulin pump warning over potential speaker malfunction
Tandem Diabetes Care (Nasdaq:TNDM) has issued an urgent medical device correction for some t:slim X2 automated insulin pumps. In a July 22 notice, the San Diego-based company warned of pumps that may exhibit a higher rate of speaker failure. During normal use, the insulin pump software monitors current flowing through the speaker during use. Measurements […]
FDA warns on Baxter infusion pump issue that potentially led to deaths
The FDA issued an early alert related to an issue with Novum IQ large-volume infusion pumps made by Baxter (NYSE:BAX). This notice comes just weeks after an initial warning about potential underinfusion with all Novum IQ large-volume pumps. That alert included reports of one serious injury and no deaths associated with the issue. Now, the FDA […]
