FDA medical device recalls

Lot FD1265 of the ZYMUTEST HIA IgG diagnostic kit was shipped with an outdated instruction flyer that contained incorrect values for the positive control. This could lead to misinterpretation of test results if users rely on the wrong reference values.

Bolts and plastic parts on the Cable Hose Carriers that attach cable hoses to the monitor ceiling suspension may loosen or break over time when the monitor is moved or rotated. This affects multiple Azurion 3, 5, and 7 model variants.

Certain lots of the Quidel QuickVue Dipstick Strep A Test may return false positive results, meaning the test could indicate a strep infection when one is not actually present. This could lead to unnecessary antibiotic treatment. The recall affects specific lot numbers distributed across the US.

Hologic's 3DIMENSIONS mammography systems may develop loose, missing, or broken internal bolts over time. This affects multiple model variants distributed nationwide. No injuries have been reported.

Hologic has recalled multiple models of Selenia Dimensions mammography systems because internal bolts can become loose, missing, or broken over time. This may affect the system's structural integrity or function. No injuries have been reported.

Stryker Corporation recalled a limited lot of FluidSmart Urology Tube Sets (REF LL0006) used with fluid management systems in surgical procedures. Some units in this lot did not meet manufacturing standards. No injuries have been reported.

A software defect in the Dexcom ONE+ iOS app (versions 1.5.0 and 1.6.0) can delay glucose value notifications when the app runs in the background. When you open the app, glucose readings may display out of order or the app may incorrectly signal loss of connection. This delay could cause you to miss alerts for dangerously high or low blood sugar, or make treatment decisions based on outdated information.

A software defect in the Dexcom G7 watchOS app (versions 2.9.0–2.11.2) can delay glucose value notifications and alerts when the app runs in the background. When you open the app, older glucose readings may flash on screen, and the app may incorrectly report a loss of signal. This delay could cause you to miss alerts for dangerously high or low blood sugar, or make treatment decisions based on outdated information.

A software defect in the Dexcom G7 continuous glucose monitoring app (versions 2.9.0–2.11.2 for iOS) can delay glucose value updates and alerts when the app runs in the background. When you open the app, notifications may replay in sequence or show outdated readings. In some cases, the app may incorrectly detect signal loss, creating a risk that users could miss high or low blood sugar alerts or make treatment decisions based on outdated information.

Diowave 250W infrared laser systems used for temporary muscle and joint pain relief are operating at a maximum power output of 70W, which exceeds the FDA-cleared limit of 60W. A software update is required to correct the power output to the approved level.

A subset of Jolife LUCAS 2, LUCAS 3, and LUCAS 3.1 chest compression devices did not have complete service documentation on file. The service records lack paperwork that would verify these devices passed their required checks. This affects 153 devices across 20 U.S. states.

A supplier defect in the 16F dual-valved splittable sheath introducer used in certain Arrow NextStep hemodialysis catheter kits may prevent the sheath from splitting as designed. This can cause difficulty during catheter placement, leading to prolonged procedures and potential complications including bleeding, tissue injury, or vessel wall damage.

A faulty component supplied by a vendor — a 16F dual-valved splittable sheath introducer — was included in certain Arrow International hemodialysis catheter kits. The sheath may fail to split as designed during insertion, potentially causing procedural delays, pain, bleeding, bruising, or tissue damage.

Arrow International is recalling specific lots of Arrow-Clark VectorFlow hemodialysis catheters because they contain a faulty sheath introducer component from a supplier. The introducer may fail to split properly during insertion, which could cause difficulty withdrawing the device, prolonged procedure time, pain, and potential bleeding or tissue injury.

Arrow International included a defective 16F dual-valved splittable sheath introducer in certain hemodialysis catheterization kits. The sheath introducer may not split properly during removal, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, and tissue or vessel wall injury.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the server. No injuries have been reported.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the system. This affects 10 units distributed nationwide.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through Edison Health Link. The vulnerability could potentially allow unauthorized access to the system. This affects 11 units worldwide.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution Apex, Revolution Ascend, and Revolution CT imaging systems when deployed through the Edison Health Link subscription service. The vulnerability could potentially allow unauthorized access to the system. No patient harm has been reported.

GE HealthCare identified a security vulnerability in the AW Server software used with certain Revolution CT, Revolution Apex, and Revolution Ascend CT scanners deployed through Edison Health Link (EHL). The vulnerability could potentially allow unauthorized access to the system. This affects 38 units worldwide.

Medline has identified particulate (small particles) in the fluid path of Namic Manifolds within certain TAVI medical convenience kits. The kits were distributed nationwide and internationally. No injuries have been reported.

Medline has identified particles inside the fluid pathways of Namic Manifolds used in cardiac catheterization kits. These kits are used during heart procedures. The contamination could potentially affect the performance of the devices during medical procedures.

Medline has identified particles in the fluid pathway of certain cardiac catheterization manifold kits used in heart procedures. The affected kits span multiple product lines and lot numbers manufactured between 2024 and 2025. No injuries have been reported.

Medline identified particles inside the fluid pathways of Namic Manifolds used in three medical convenience kits: Angiography Cath Lab, Cath Lab Pack, and Angio Kit. These particles could potentially affect the performance of the manifold during use. Approximately 508 kits have been distributed across the U.S. and several other countries.

Medline has identified particulate matter inside the fluid pathway of certain Namic Preceptor Manifold blood pressure transducers. This contamination could affect the accuracy of blood pressure readings or damage the device during use. No injuries have been reported to date.

Medline has identified particles inside the fluid path of certain Namic Preceptor Manifold blood pressure transducers. These particles could interfere with accurate blood pressure readings or damage the device during use.

Medline identified small particles present inside the fluid pathways of certain Namic Angiographic Manifolds used in cardiac bypass procedures. These manifolds are medical devices that control and direct fluid flow during heart surgery. The contamination was discovered in 1,975 units across multiple lot numbers.

Medline has identified particles in the fluid pathway of certain Namic Angiographic Manifolds used in cardiopulmonary bypass procedures. These manifolds are used to manage fluid flow during heart and lung bypass surgery. The contamination could potentially affect the safety and performance of the device during use.

Medline Industries identified particulate matter in the fluid path of certain Namic Angiographic Manifolds used in cardiopulmonary bypass procedures. The contamination could potentially affect the safety and performance of these critical medical devices during use.

Some DJO IceMan CLASSIC3 cold therapy units (model 11-9099, lot 110525) have a broken connector that may temporarily interrupt cold therapy during treatment. No injuries have been reported. The issue affects about 96 units distributed across the US and Canada.