January 21, 2026Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV DSI, System, Tomography, Computed, Emission
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
January 21, 2026Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV DSX New Line, System, Tomography, Computed, Emission
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
January 21, 2026Medical DevicesFDA
Medtronic Neuromodulation recalls A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software
Hazard: Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
January 21, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H
Hazard: Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
January 21, 2026Medical DevicesFDA
Mobius Imaging, LLC recalls Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Hazard: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
January 21, 2026Medical DevicesFDA
Mobius Imaging, LLC recalls Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Hazard: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
January 21, 2026Medical DevicesFDA
Medicrea International recalls Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Hazard: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
January 21, 2026Medical DevicesFDA
Medicrea International recalls Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Hazard: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
January 21, 2026Medical DevicesFDA
REPLIGEN CORPORATION recalls MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-014
Hazard: Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.
January 21, 2026Medical DevicesFDA
Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component
Hazard: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
January 21, 2026Medical DevicesFDA
Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component
Hazard: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
January 21, 2026Medical DevicesFDA
Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component
Hazard: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
January 21, 2026Medical DevicesFDA
Abbott Diabetes Care, Inc. recalls FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the Fr
Hazard: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
January 21, 2026Medical DevicesFDA
Canon Medical System, USA, INC. recalls VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Hazard: 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.
January 21, 2026Medical DevicesFDA
Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Hazard: 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.
January 14, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of t
Hazard: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
January 14, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when di
Hazard: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
January 14, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK
Hazard: Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
January 14, 2026Medical DevicesFDA
IMRIS Imaging Inc recalls Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000,
Hazard: Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
January 14, 2026Medical DevicesFDA
Philips North America Llc recalls Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Hazard: It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
January 14, 2026Medical DevicesFDA
Securitas Healthcare LLC recalls Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Hazard: Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
January 14, 2026Medical DevicesFDA
Securitas Healthcare LLC recalls Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
Hazard: Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
January 14, 2026Medical DevicesFDA
Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Hazard: Device packaged in incorrect outer box carton.
January 14, 2026Medical DevicesFDA
Sophysa recalls The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Hazard: Customer complaints of Pressio monitor rebooting.
January 14, 2026Medical DevicesFDA
CareFusion 303, Inc. recalls BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03,
Hazard: Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
January 14, 2026Medical DevicesFDA
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel
Hazard: 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.
January 14, 2026Medical DevicesFDA
Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Hazard: Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
January 14, 2026Medical DevicesFDA
Beckman Coulter, Inc. recalls Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Hazard: Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
January 14, 2026Medical DevicesFDA
Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Hazard: The affected lots show a decline in performance over time, which may lead to false-negative results.
January 14, 2026Medical DevicesFDA
Applied Medical Resources Corp recalls Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Hazard: There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.