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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

Philips is recalling 16 Allura Xper imaging system models because a drip tray under the cooling unit may not have been installed during earlier field corrections, or the installation was not properly documented. Without the tray, coolant could reach electrical components, possibly causing short-circuits, blown fuses, or system shutdown. No injuries have been reported.

Moderate·FDA·Jan 21, 202616 products

BD Ready-to-Use Hydrophilic Catheters (14 Fr, straight tip, model RTU14F) distributed in Georgia have an incorrect expiration date printed on the label. This labeling error means the actual shelf life of the product may differ from what is shown. No injuries have been reported.

Moderate·FDA·Jan 21, 2026·Bever

Medline is recalling 12 kits that contain B. Braun IV administration sets and pump administration sets. Customers reported that the check valve components in these sets can get stuck in the open or closed position. No injuries have been reported.

Moderate·FDA·Jan 21, 202612 products

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.

Moderate·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

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.

Moderate·FDA·Jan 21, 2026·Medtronic Neuromodulation

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.

Moderate·FDA·Jan 21, 2026

Mobius Imaging is recalling two products for the AIRO Computed Tomography (CT) X-ray System: a replacement pendant component and a pendant upgrade component. The pendants do not have the required "Safe Hand Position Warning" label. No injuries have been reported.

Moderate·FDA·Jan 21, 2026·Mobius Imaging2 products

Medicrea is recalling two IB3D surgical products, the Universal Implant Inserter and the PL Instruments Set, because the rotation tool handle may separate from its shaft. If that happens, the surgeon may be unable to rotate the implant. The company reports 44 units of each product affected, and no injuries have been reported.

Moderate·FDA·Jan 21, 2026·Medicrea2 products

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.

Moderate·FDA·Jan 21, 2026

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

Canon is recalling 2 Vantage 3T MRI models, with 56 systems affected in total. Ice can form in the venting system of the superconducting magnet, so if a quench occurs, helium gas may not escape through its vent paths, and pressure in the helium vessel can rise. This could eventually rupture the vessel and release helium gas into the MR scanning room. No injuries have been reported.

Moderate·FDA·Jan 21, 20262 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

Cipla USA is recalling certain pre-filled syringes of Lanreotide Injection 120 mg because they may contain particulate matter (small particles) in the solution. The affected syringes have specific lot numbers and expiration dates between October 2026 and March 2027. No injuries have been reported so far.

Moderate·FDA·Jan 21, 2026

Gold Star Distribution is recalling 27 over-the-counter products, including pain relievers, cold and flu medicines, antacids, cough drops, skin and lip care, petroleum jelly, rubbing alcohol and mouthwash. The products were stored or distributed from a facility with insanitary conditions, including rodent exposure and activity. No injuries have been reported.

Moderate·FDA·Jan 21, 202627 products

Encon Safety Products is recalling specific lots of AQ 120 GFEW Aquarion Preserved Cartridges due to manufacturing process deviations that do not meet FDA standards. The cartridges were distributed nationwide. No injuries have been reported.

Moderate·FDA·Jan 21, 2026·Encon Safety Products

One bottle of Alvogen Thyro-Tabs 150mcg levothyroxine tablets (Lot MHA21825) was found to contain 88mcg tablets instead of the labeled 150mcg strength. This mix-up affects only a single bottle distributed nationwide. No injuries have been reported.

Moderate·FDA·Jan 21, 2026·Alvogen

Advanced Pharmaceutical Technology is recalling TESTO-100 CIII testosterone pellets (Lot P-22-3, expiration 06-2027) because they may not be sterile and could be contaminated with harmful microbes. These are prescription implant pellets used for testosterone replacement therapy. The recall affects 22,843 pellets distributed in Georgia, New York, Texas, Puerto Rico, the United Kingdom, Malta, and Greece.

Moderate·FDA·Jan 21, 2026·Advanced Pharmaceutical Technology

Sun Pharmaceutical has recalled three lots of clindamycin phosphate 1% topical solution due to failed quality tests. The affected batches contain higher-than-acceptable impurities and may not contain the correct amount of active ingredient, which could reduce effectiveness.

Moderate·FDA·Jan 21, 2026

Taro Pharmaceuticals is recalling specific lots of fluocinolone acetonide topical solution (0.01%) because testing found higher-than-allowed levels of an impurity. The affected lots were distributed nationwide. No injuries have been reported.

Moderate·FDA·Jan 21, 2026

Integra LifeSciences is recalling two Codman ICP monitoring kits, the Microsensor Basic Kit and the CereLink ICP Sensor Basic Kit, because the 14-gauge Tuohy needle included in them may have corrosion stains on its surface. About 6,400 units are affected, and the kits were distributed in the US and in many other countries. No injuries have been reported.

Moderate·FDA·Jan 14, 20262 products

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

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.

Moderate·FDA·Jan 14, 2026

Securitas Healthcare found a firmware problem in certain Arial 900 MHz Call Stations that may stop them from sending a low battery alert to the Arial Wireless Emergency Call System before the battery fails. The recall covers 2 products, models CSK200-900 and CSK200-900MR, with firmware version 1.6.3, and no injuries have been reported.

Moderate·FDA·Jan 14, 2026·Securitas Healthcare2 products

Abiomed has recalled 2 units of the Impella 5.5 with SmartAssist S2 heart pump device because the devices were shipped in incorrect outer box cartons. This packaging error may affect proper device identification and handling. No injuries have been reported.

Moderate·FDA·Jan 14, 2026

Sophysa's Pressio 2 ICP Monitoring System (Model PSO-4000) may unexpectedly reboot during use. This device is used in hospitals to measure pressure inside the skull. The reboots could interrupt critical monitoring of patients.

Moderate·FDA·Jan 14, 2026·Sophysa

A software issue in certain BD Pyxis ES Enterprise Server systems may prevent timely updates of patient, medication, and related information from reaching the dispensing cabinets. This could delay access to critical data in healthcare settings. BD and the FDA are working to address the problem.

Moderate·FDA·Jan 14, 2026

Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.

FDA·Jan 14, 2026·Remote Diagnostic Technologies