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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

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

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 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 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.

Moderate·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

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.

Moderate·FDA·Jan 21, 20262 products

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

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.

Moderate·FDA·Jan 14, 20262 products

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