Medical device recalls

Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

Medline kits labeled DR HOLCOMB FACIAL PACK (SKU DYNJ54488A) contain B. Braun IV Administration Sets with check valve components that may become stuck in the open or closed position. This can prevent proper fluid flow during IV administration. The recall affects 16 units distributed nationwide.

Medline kits containing B. Braun IV Administration Sets have been recalled because the check valve components may get stuck in either the open or closed position. This could affect how medication or fluids flow through the IV line. No injuries have been reported, but the sets should not be used.

Medline surgical kits containing B. Braun IV administration sets may have check valve components that become stuck in the open or closed position. This could affect fluid delivery during medical procedures. About 96 kits are affected.

Medline Deluxe Pre Op Kits containing B. Braun IV Administration Sets may have check valve components that stick in the open or closed position. This could affect the proper flow of intravenous fluids during medical procedures. The issue affects specific lot numbers distributed nationwide.

Medline has recalled eight models of cardiac surgery kits that contain B. Braun IV administration sets. The check valve components in these sets may become stuck in either the open or closed position, which could affect fluid delivery during surgery. No injuries have been reported.

Medline kits containing B. Braun IV administration sets have been recalled because the check valve components may become stuck in the open or closed position. This could prevent proper fluid flow during medical procedures. The recall affects 10 units distributed nationwide.

Fresenius Kabi is issuing a recall for the Ivenix Infusion System (IIS) with LVP Software version 5.10.2 and earlier. The manufacturer is emphasizing instructions for LVP duration programming in the device manual to ensure proper use. No injuries have been reported.

GE HealthCare identified that certain older GE MAXXUS Nuclear Medicine systems may have been moved or transported without proper detector support. This could damage the detector mounting and potentially cause the detector to fall, which poses a serious injury risk. No injuries or detector falls have been reported so far.

GE HealthCare identified that certain older SMV BodyTrack nuclear medicine systems may have been moved or transported without proper detector support during their service life. This can weaken the detector mounting mechanisms. If the detector becomes loose or falls, it could cause serious injury. No injuries or detector falls have been reported so far.

GE HealthCare discovered that certain older SMV DSI nuclear medicine systems may have been moved or transported without proper detector support. This can stress the detector mounting and potentially cause the detector to fall, which could injure someone. No falls or injuries have occurred yet.

GE HealthCare identified that certain older SMV DSX nuclear medicine systems may not have been properly supported during transport or relocation. This could damage the detector mounting mechanisms and potentially cause the detector to fall, creating a serious safety risk. No injuries have been reported so far.

The Vanta A71200 Clinician Programmer App (versions 2.0.2465 and 2.0.2683) running on Samsung tablets may not work properly during use. This malfunction could delay or postpone surgical procedures. The implanted neurostimulator devices themselves are not affected—only the programming software.

Boston Scientific found that certain batches of Coyote Over-the-Wire PTA Balloon Dilation Catheters may not inflate or deflate properly during use due to a manufacturing process variation. The issue affects only catheters made between September 12 and October 13, 2025. The company has corrected the manufacturing process.

Mobius Imaging's detachable 10-inch pendant upgrade kits for AIRO Computed Tomography systems are missing a required "Safe Hand Position Warning" label. This label is important for safe operation of the equipment. The affected units were distributed nationwide.

Mobius Imaging recalled certain replacement pendant components for AIRO CT X-ray systems because they are missing a required "Safe Hand Position Warning" label. The label is important safety information for users of the equipment. No injuries have been reported.

The handle on the orthopedic rotation tool in Medicrea's IB3D PL Instruments Set may become detached from the shaft during surgery, preventing proper rotation of the implant. This affects 44 units distributed across multiple U.S. states. No injuries have been reported.

Medicrea's IB3D Universal Implant Inserter tool handle may separate from the shaft during surgery, preventing the surgeon from rotating the implant as intended. The issue affects 44 units across multiple states. No injuries have been reported.

Repligen is recalling the MAVERICK Measurement Module Spectrometer due to cable connection defects that can cause two problems: the laser output may increase to unsafe levels, or the laser may fire unexpectedly during normal operation. A loose or poorly crimped cable under stress can trigger these faults. No injuries have been reported.

Abbott Diabetes Care is recalling certain FreeStyle Libre 3 Plus continuous glucose monitoring sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup could lead to incorrect low blood sugar readings, which may not alert you when your glucose is actually low.

Abbott has recalled certain FreeStyle Libre 3 Plus glucose sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup can result in the sensor showing incorrect low blood sugar readings when your actual glucose is normal or higher. The recall affects specific lot numbers with expiration date of 01/31/2026.

Abbott has recalled certain FreeStyle Libre 3 Plus glucose sensors due to a manufacturing issue that may cause carbon buildup inside the sensor. This buildup could result in the sensor showing incorrect low blood sugar readings when your actual glucose is normal or high.

Abbott is recalling certain FreeStyle Libre 3 sensors due to a manufacturing defect that may cause carbon buildup inside the sensor. This buildup can result in the sensor showing incorrect low blood sugar readings when your actual glucose level is normal or higher. The recall affects sensors with specific lot and serial numbers expiring by December 31, 2025.

Ice can form in the venting system of Canon Medical VANTAGE TITAN 3T MRI machines (models MRT-3010/MEXL-3010). If the system undergoes a quench event while ice is present, helium gas may not escape properly and pressure inside the helium vessel could build up and rupture, releasing helium gas into the scanning room.

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.

The 14-gauge Tuohy needle included in certain Codman CereLink ICP Sensor Basic Kits may have corrosion stains on its surface. These kits are used by hospitals and surgical centers for monitoring intracranial pressure during brain procedures. Integra LifeSciences is recalling specific lot numbers distributed worldwide.

Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.

Medline Industries is recalling multiple models of Hudson RCI oxygen masks because the tubing can disconnect during use. If this happens, oxygen delivery stops, which can delay patient care and cause breathing problems that may require medical intervention.

The torque screw in certain IMRIS HFD100 Head Fixation Devices may crack or separate during use. This could cause the device to fail to hold a patient's head securely during surgery, potentially affecting surgical accuracy and requiring emergency use of backup fixation methods.

Philips MX40 patient monitors may lose wireless connection to the PIC iX central station when moving between certain access points if the signal strength changes rapidly. This could interrupt patient data transmission to clinical staff.