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Mazor Robotics has recalled its Mazor X robotic guidance system due to software errors in certain versions that could cause incorrect positioning of surgical instruments during spinal surgery. The affected software versions are 5.0.1, 5.1.2, and 5.1.3. About 549 systems worldwide are affected, and no injuries have been reported.

Serious·FDA·Jan 28, 2026·Mazor Robotics

Baxter Healthcare has recalled certain SIGMA Spectrum infusion pumps (model 35700BAX2) because they may contain defective grease on internal gears. This defective grease does not lubricate properly, which can cause premature wear of the pump mechanism and lead to the pump delivering too much medication or allowing medication to flow freely without stopping.

Serious·FDA·Jan 28, 2026

ICU Medical's Tego Connector needle-free access devices have a silicone seal that may bulge, separate, or tear. This defect can cause fluid leaks, blockages, inability to draw or inject medication, and potential exposure to contamination or air in the bloodstream during hemodialysis or IV therapy.

Serious·FDA·Jan 28, 2026

RaySearch RayStation/RayPlan radiation therapy planning software (versions 11B through 11B SPT1) has a bug that prevents dose calculations from updating correctly when changes are made to certain regions of interest with material overrides or specific geometry types. This could result in treatment plans using outdated radiation dose calculations.

Serious·FDA·Jan 28, 2026·Raysearch Laboratories9 products

Medline is recalling six models of electric homecare beds, about 599,000 units in total. In rare cases, such as overloading the bed, an obstruction blocking its movement, or a jammed motor, the hand control pendant and its cords can overheat and, in rare instances, catch fire. Medline has received 58 complaints of pendants sparking, burning, melting, smoking, or catching fire. No injuries have been reported.

Serious·FDA·Jan 28, 20266 products

Thoratec CentriMag blood pump components used in acute circulatory support and ECMO systems may not lock securely into the motor. If the pump fails to lock properly, the system may not generate an alarm, which could delay critical heart support or cause serious complications.

Serious·FDA·Jan 21, 2026

ICU Medical identified a batch of defective speakers in some Plum Duo Infusion Pumps that may fail silently. If the speaker fails, the pump will not produce audible alarms, alerts, or sound feedback when you touch the screen. This could delay recognition of important pump notifications.

Serious·FDA·Jan 21, 2026

The Catalyst+ patient positioning system used in stereotactic radiosurgery (a type of radiation therapy) has a software issue that may cause incorrect patient positioning. In some cases, the system may show a patient is correctly positioned when they are actually outside the safe treatment area, which could affect treatment accuracy.

Serious·FDA·Jan 21, 2026·C-RAD

Philips Medical Systems has recalled Azurion Systems R3.0 due to nine software issues that may cause X-ray loss, system restarts, display problems, or imaging misalignment during procedures. These issues could affect image quality and system reliability in clinical use.

Serious·FDA·Jan 21, 2026

Certain versions of Elekta's MOSAIQ oncology information system may deliver twice the intended radiation dose to cancer patients under specific conditions involving partial treatments and interrupted fields. This could occur when the system fails to verify the correct dose amount after a treatment interruption. The issue affects systems using particle therapy with certain software versions.

Serious·FDA·Jan 21, 2026

GE HealthCare is recalling four older nuclear medicine imaging systems, 60 units in total, that are past their end of guaranteed service. The systems may have been moved without proper detector support, which could stress the detector mounts and lead to a detector falling. No falls or injuries have been reported.

Serious·FDA·Jan 21, 20264 products

Abbott is recalling four FreeStyle Libre 3 and Libre 3 Plus glucose sensor models, about 3 million sensors in total. A manufacturing problem may cause carbon buildup in the sensor, which can lead to incorrect low glucose results. No injuries have been reported.

Serious·FDA·Jan 21, 20264 products

Healthy Truth brand Moringa Powder in 5lb and 20lb bags may be contaminated with Salmonella Richmond. The contamination was discovered during routine testing. No illnesses have been reported yet.

Serious·FDA·Jan 21, 2026

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.

Serious·FDA·Jan 14, 2026

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.

Serious·FDA·Jan 14, 2026·IMRIS

AVID Medical is recalling three Halyard kits, totaling 564 units, because the devices are not suitable for organ transplant. The kits were distributed nationwide, with US distribution in Florida, Georgia, and Puerto Rico. No injuries have been reported.

Serious·FDA·Jan 14, 20263 products

MediNatura is recalling two nasal sprays: ReBoost Nasal Spray and ClearLife Allergy Nasal Spray, Extra Strength, both in 20 mL bottles. FDA found yeast, mold and Achromobacter bacteria in the products, which are not sterile. No injuries have been reported.

Serious·FDA·Jan 14, 2026·Medinatura2 products

Diasol has recalled specific lots of its liquid concentrate used in bicarbonate dialysis machines. The FDA determined that the safety and efficacy of this product cannot be assured. The recall affects 7,200 gallons distributed across six states.

Serious·FDA·Dec 31, 2025·Diasol6 products

Zimmer, Inc. recalled certain Affixus 9 mm femoral nails (model 815509360, length 360 mm) because the shaft may be undersized and prone to breaking. If the implant fractures, it could cause pain, improper bone healing, tissue damage, or require additional surgery.

Serious·FDA·Dec 31, 202517 products

Alcon Custom Pak sterile surgical procedure packs used in eye surgery may have incomplete seals that could compromise sterility. This affects 151 units across specific lot numbers. No injuries have been reported.

Serious·FDA·Dec 31, 2025

Draeger, Inc. is recalling certain Vapor 2000 anesthetic vaporizers because an internal component was manufactured with impurities and did not meet quality specifications. The affected units are identified by specific serial numbers and were distributed worldwide, including across the United States.

Serious·FDA·Dec 31, 20252 products

Abbott Laboratories is recalling certain Alinity ci-series System Control Modules with software version 3.6.1 or lower due to a performance issue that could produce inaccurate lab test results. The issue affects multiple analytes and was discovered during Abbott's internal testing.

Serious·FDA·Dec 24, 2025

A speaker component change in certain PATH Madsen Accuscreen DPOAE probes can cause technical distortions that mimic real hearing responses. This may result in incorrect "PASS" outcomes on infant hearing screening tests when a baby should have failed. The issue occurs when high stimulus levels combine with the device's sensitivity settings.

Serious·FDA·Dec 24, 2025·PATH

Fresenius Medical Care identified several software problems in the 5008X CAREsystem +CLiC +CDX dialysis machine that could interfere with patient treatment. One anomaly could potentially cause the machine to stop treatment if certain conditions occur. This affects 115 units with software versions older than 4.82.4.

Serious·FDA·Dec 24, 2025

GE Healthcare is recalling certain Carestation 600 and 700 Series anesthesia systems, along with a related power management board part, because they may unexpectedly shut down if AC power is unplugged or lost. These systems have no continuous backup power and do not automatically switch to battery, so they reboot and may briefly interrupt ventilation and anesthetic delivery without returning to previous settings. The recall covers 3 product entries with about 2,368 units affected, and no injuries have been reported.

Serious·FDA·Dec 24, 20253 products

Fresenius Kabi has recalled software version 5.10.1 and earlier for the Ivenix Infusion System due to anomalies that could cause serious patient harm. The affected software is used to control the delivery of fluids to patients in medical settings. About 30 units have been distributed across multiple U.S. states.

Serious·FDA·Dec 24, 2025

The Whole Herb Company is recalling senna leaves (Item No. SEN15001, Lot No. 003279ST) because they may be contaminated with Salmonella. The recall affects approximately 3,580 pounds of product distributed in California, New Jersey, and Canada.

Serious·FDA·Dec 24, 2025

Food to Live brand Organic Supergreens Powder Mix has been recalled because it may be contaminated with Salmonella, a bacteria that can cause serious illness. The affected product comes in multiple sizes (8 oz to 12 lb) with lot codes between SO-69006 and SO-72558.

Serious·FDA·Dec 24, 20252 products

Draeger's ErgoStar CM 40 airway connectors (model MP01840) have developed cracks in the hose during use. This connector is used in breathing systems for mechanically ventilated patients. Multiple complaints have been reported worldwide, and all lot numbers are affected.

Serious·FDA·Dec 17, 20254 products