Medical device recalls

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.

Some DJO DONJOY IceMan CLASSIC3 cold therapy units (model 11-1424) have a broken connector that can interrupt cold therapy temporarily. This affects prescribed rehabilitation treatments. No injuries have been reported.

Some DJO DONJOY ICEMAN CLASSIC3 cold therapy units (model 11-1422) may have a broken connector that could temporarily stop the cold therapy from working as prescribed. The connector failure affects specific production lots and has been identified in devices distributed across the U.S. and Canada. No injuries have been reported.

Some DONJOY ICEMAN CLASSIC CUBE cold therapy units (model 11-0494) contain a broken connector that may temporarily interrupt cold therapy during treatment. This affects units from specific lot codes distributed across the U.S. and Canada. No injuries have been reported.

On-X Life Technologies released and distributed 10 mitral heart valves (Model ONXMC-25/33) before completing all required quality and performance testing. Because testing was incomplete, the company cannot confirm the valves meet all safety and performance specifications. The affected valves were distributed internationally to South Korea.

Windstone Medical Packaging's Custom Convenience Kit (Angio Pack, part numbers AMS6908E and AMS6908F) contains Medline Namic angiographic syringes with a defect: the rotating adapter can unwind during use, causing the syringe to loosen or fully disconnect from the manifold. This disconnection could expose patients to biohazard contamination, blood loss, infection, or air embolism.

Certain rolls of label stock used in Omnicell i.v.Station devices may produce mislabeled syringes during IV medication preparation. The i.v.Station is a pharmacy automation device that compounds IV medications and applies identification labels. Mislabeled syringes could lead to medication identification errors.

Philips has identified three software issues in the Spectral CT on Rails Model 728334 that may affect scan operations. The gantry (rotating scanner) may not move to the correct position after pressing start; a required confirmation message may not appear; and a menu option may become unavailable during brain imaging setup. Three systems worldwide are affected.

Medline distributed one lot of CENTURION Circumcision Kits (lot number 25KLA002) without completing the required sterilization process. This means the kits are not sterile and could pose an infection risk if used. The affected kits were distributed in South Carolina.

The Gentuity HF-OCT Imaging System may display repeated image frames during a pullback procedure when used with certain catheters, which could affect the accuracy of length measurements. This issue affects specific software versions (21.11 to 23.3.13) paired with Vis-Rx and Vis-Rx Prime catheters. No injuries have been reported.

The centrifuge bowl on certain Cellex Photopheresis System kits may be difficult to install properly onto its holder. If not installed correctly, the bowl can break during use, which could delay patient treatment and cause blood loss.

Clariance-SAS is recalling multiple lots of Elegance Anterior Cervical Plates (used in neck spine surgery) due to burrs found on some finished plates. The burrs are sharp edges that could cause injury during or after implantation. No injuries have been reported so far.

Integra LifeSciences' Cytal Burn Matrix 10x15 cm (Product ID: BMM1015) has been recalled because certain lots tested at higher-than-acceptable endotoxin levels. Endotoxins are bacterial substances that can trigger inflammatory reactions when in contact with body tissues. The FDA identified this issue across 226 units distributed nationwide.

Integra LifeSciences has recalled specific lots of Cytal Burn Matrix (a burn wound dressing) because testing found higher-than-acceptable levels of endotoxin, a bacterial substance that can trigger an immune response. Seven units were distributed across the U.S. No injuries have been reported.

Increased rate of out-of-specification endotoxin results.

Integra LifeSciences' Cytal Wound Matrix 2-Layer (7x10 cm) from specific lot numbers tested higher than safe endotoxin levels. Endotoxins are bacterial substances that can trigger harmful immune responses. No injuries have been reported so far.

Integra LifeSciences' Cytal Wound Matrix 2-Layer 5x5 cm wound dressing (Product ID: WSM0505) has been recalled because some units have higher-than-safe levels of endotoxin, a bacterial substance that can trigger immune reactions. The affected product was distributed nationwide, and no injuries have been reported so far.

3B Medical distributed 2 units of the React Health PHOENIX 5L Oxygen Concentrator that did not meet the company's internal quality standards. The devices were distributed in New York. No injuries have been reported.

Siemens has recalled certain ARTIS Pheno VE30A and VE40A imaging systems used in hospitals and medical facilities. During 3D imaging procedures, these systems may produce images with uneven brightness, potentially leading to less accurate reconstructions and unintended low-dose radiation exposure to patients.

Wilson-Cook Medical is recalling Instinct Plus Endoscopic Clipping Devices (model G58010) due to increased complaints about potential device malfunction during use. The recall affects units manufactured between September 2, 2023 and April 20, 2025 and distributed worldwide. No injuries have been reported.

Certain Arjo Tenor mobile patient lifts contain actuators with an internal component that may not be strong enough to safely hold the load. In the worst case, this could cause the lifting arm to suddenly drop uncontrolled. This affects 119 units with specific serial numbers manufactured in certain batches.

The LinkBio CORE Workstation, part of the CORE Shoulder System, may show an incorrect Planning Date when you view cases in the Start Case menu. This could lead to confusion about case timing. Five units are affected across Alabama, Florida, and Kansas.

Certain versions of the iLet Ace Pump software (1.3.7, 1.4.2, and 1.4.3) have a security flaw that allows someone to bypass the Lock Screen and Limited Access Passcode Screen by pressing icons in the status bar. This could let an unauthorized person make false meal announcements or stop insulin delivery, risking severe low blood sugar.

Remel's Yeastone Broth (11ML, 10/BOX, model YY3462) may give wrong results when labs use it to test how fungi respond to antifungal medicines. If a lab doesn't catch the bad result during its own quality checks, doctors might delay treatment or switch to a different antifungal drug unnecessarily.

Philips AneurysmFlow is software used by doctors to help evaluate aneurysm treatment with flow diverter stents. The software's Mean Aneurysm Flow Amplitude (MAFA) ratio does not reliably predict whether the aneurysm is successfully closed, but doctors may be using it to make treatment decisions based on the user manual.

B Braun Medical Inc is recalling specific hemodialysis bloodline tubing (Model B3-4630M4705) because small air bubbles can accumulate in the arterial line when blood gases stick to the tubing under negative pressure. This could affect dialysis treatment safety. The recall affects units manufactured since August 5, 2025.

B. Braun Medical Inc is recalling specific hemodialysis bloodline tubing because small air bubbles can accumulate in the arterial line during dialysis treatment. This happens when blood gases stick to the tubing when negative pressure is applied. The affected units were manufactured on or after August 1, 2025.

B. Braun Medical Inc is recalling certain hemodialysis bloodlines (model SL-2000M2095L) because small air bubbles can collect in the arterial line when the tubing is under negative pressure. This happens because blood gases stick to the inside of the tubing. No injuries have been reported.

Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.