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Sysmex America's TS-10/TS-10H Tube Sorter may experience an unexpected loss of electromagnetic holding force in the lift mechanism under certain conditions. This could cause the lift to move downward unintentionally. The issue affects 44 specific units identified by serial number.

Moderate·FDA·Jan 28, 2026·Sysmex

Beckman Coulter's LDL Cholesterol OSR6x96 reagent may give inaccurate test results when patients have high triglyceride levels (above 1500 mg/dL). The test can overestimate LDL cholesterol by up to 29% in some samples, which could affect patient care decisions.

Moderate·FDA·Jan 28, 2026

Intuitive Surgical has recalled certain Ion Vision Probe Bags (model 490127) because the sterile pouch seal may be compromised or incomplete. These bags are used to store the Vision Probe during lung biopsy procedures. A compromised seal could allow contamination of the sterile device.

Moderate·FDA·Jan 28, 2026

MicroPort Orthopedics distributed a hip implant trial component (HIPTURN FEM HEAD TRIAL 36MM) in the United States without FDA premarket authorization. The company sent approximately 91 units to distributors across multiple states. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·MicroPort Orthopedics

Tyber Medical is recalling two sizes of left distal radius plates from its VOLT Wrist Treatment System, 164 units in total. The supplier made the plates with threads facing the wrong direction. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·Tyber Medical2 products

Two Leaseir MHR Xcell surgical lasers used for hair removal and skin treatment were distributed with console labels missing the required "DANGER" symbol. The missing warning label could prevent users from recognizing laser hazard warnings. No injuries have been reported.

Moderate·FDA·Jan 28, 2026·Leaseir Technologies

Merit Medical is recalling seven inflation devices and kits, including Allwell and Merit Medical products. The inflation device handle may detach from the syringe during a procedure. No injuries have been reported.

Moderate·FDA·Jan 28, 20267 products

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

Philips has identified two software issues in Azurion R3.1 systems that may cause the device to restart continuously, lose X-ray imaging capability, lose motorized movement, display incorrect images, or lose data. One issue affects all models; a second affects only systems with a Poly-G3 frontal stand.

Moderate·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 Laboratories is recalling nine RayStation and RayPlan radiation therapy treatment planning software entries. Certain regions of interest with no contours, which have a material override or are of type Bolus, Fixation, or Support, may not invalidate calculated radiation dose as intended when their geometry is changed or their material override is removed. No injuries have been reported.

Moderate·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

Zydus Pharmaceuticals is recalling Icosapent Ethyl 1-gram capsules because some bottles may contain capsules that have lost potency (strength) due to leakage and oxidation. This means the medication may not work as intended. The recall affects specific lot numbers expiring in February and April 2027.

Moderate·FDA·Jan 28, 2026

Specialty Process Labs is recalling one lot of Thyroid, USP (an active pharmaceutical ingredient used in manufacturing) because it does not meet strength standards. The affected lot may contain less active ingredient than labeled, which could affect the potency of products made with it.

Moderate·FDA·Jan 28, 2026·Specialty Process Labs

Rising Pharmaceuticals is recalling Furosemide Tablets, USP 40 mg (a water pill used to treat swelling and high blood pressure) because some bottles may contain a foreign substance. The affected lot is FUB125042G with an expiration date of May 2027. This recall affects 4,212 bottles distributed nationwide.

Moderate·FDA·Jan 28, 2026·Graviti Pharmaceuticals

Cipla USA is recalling Diclofenac Sodium Topical Gel 1% (batch XHBG, expiring 08/31/2027) because it failed to meet required pH specifications during quality testing. The gel may not work as intended or could cause skin irritation. No injuries have been reported so far.

Moderate·FDA·Jan 28, 2026

ICU Medical is recalling two products, the Pulsator Arterial Blood Sampling Kit and the Portex Spinal Tray, with 64,290 affected units each. Some syringes may have a crack on the syringe collar, which can cause delayed or repeated blood draws or fluid delivery, and blood leakage during arterial sampling or fluid delivery. No injuries have been reported.

Moderate·FDA·Jan 21, 20262 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

Medtronic has recalled certain Abre Venous Self-Expanding Stents due to a manufacturing issue with the stent material (Nitinol) that can cause the stent to be smaller than intended when deployed. This reduced size may result in the stent moving out of position after placement.

Moderate·FDA·Jan 21, 2026

Intuitive Surgical is recalling certain da Vinci SP Access Port Kits because the sterile trays may develop cracks during storage or handling. A cracked tray could allow bacteria or other contaminants to enter, compromising the sterile field during surgery. No injuries have been reported.

Moderate·FDA·Jan 21, 2026

Instrumentation Laboratory has recalled a coagulation test reagent (Part Number 0020006800, Lot N1136730) used to evaluate blood clotting and monitor heparin therapy due to potential microbial contamination. The affected lot expires 12/31/2025 and was distributed worldwide including multiple U.S. states and countries. No injuries have been reported to date.

Moderate·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

Hologic's ThinPrep CytoLyt Solution (a buffered cell wash used in laboratory testing) from lot number 5062EC has been found to contain fungal contamination. The affected product was distributed nationwide. No injuries have been reported.

Moderate·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 Azurion X-ray imaging systems running software versions R2.1.10 or R2.2.10 may experience six different software problems. These include unexpected system restarts, continuous restart loops, storage space issues, and positioning errors that could affect image quality or system availability.

Moderate·FDA·Jan 21, 2026

Medline is recalling six groups of surgical convenience kits, about 59,000 units in total, that include Stryker Strykeflow 2 Suction Irrigators. A 2024 design change lets irrigation solution reach the handpiece and battery pack, which can cause the device to leak or give off vaporized saline that may look like smoke. No injuries have been reported.

Moderate·FDA·Jan 21, 20266 products

Diagnostica Stago is recalling lot 271288 of the Asserachrom HPIA test kit, which detects antibodies related to heparin-induced thrombocytopenia (HIT type II). The affected lot may have defective test wells that produce false negative results, meaning the test could fail to detect the condition when it is present.

Moderate·FDA·Jan 21, 2026

Heraeus is recalling four PALACOS bone cement products sold in 17 countries outside the US. Some ampoules may not break during mixing, so no usable cement forms and the product cannot be used on a patient. No injuries have been reported.

Moderate·FDA·Jan 21, 2026·Heraeus4 products

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