Medical device recalls (page 25)
2545 recalls.
- RayStation/RayPlan. Model/Catalog Numbers: 11.0.0 recall (RAYSEARCH LABORATORIES AB)
Medical deviceClass IIReported January 28, 2026 · Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some... - RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan... recall (RAYSEARCH LABORATORIES AB)
Medical deviceClass IIReported January 28, 2026 · Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some... - MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed recall (Medline Industries, LP)
Medical deviceClass IReported January 28, 2026 · Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating... - MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed recall (Medline Industries, LP)
Medical deviceClass IReported January 28, 2026 · Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating... - MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed recall (Medline Industries, LP)
Medical deviceClass IReported January 28, 2026 · Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating... - MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed recall (Medline Industries, LP)
Medical deviceClass IReported January 28, 2026 · Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating... - MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed recall (Medline Industries, LP)
Medical deviceClass IReported January 28, 2026 · Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating... - MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed recall (Medline Industries, LP)
Medical deviceClass IReported January 28, 2026 · Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating... - Portex Spinal Tray recall (ICU Medical Inc.)
Medical deviceClass IIReported January 21, 2026 · Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to... - Pulsator Arterial Blood Sampling Kit recall (ICU Medical Inc.)
Medical deviceClass IIReported January 21, 2026 · Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to... - Abre Venous Self-Expanding Stent System recall (Medtronic Inc)
Medical deviceClass IIReported January 21, 2026 · Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in... - da Vinci SP recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported January 21, 2026 · Access Port System tray may develop cracks potentially resulting in a sterility breach. - The product is used for the evaluation of the intrinsic coagulation pathway recall (Instrumentation Laboratory)
Medical deviceClass IIReported January 21, 2026 · Potential for microbial contamination. - Plum Duo Infusion System recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 21, 2026 · ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo... - ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. recall (Hologic, Inc)
Medical deviceClass IIReported January 21, 2026 · Fungal contamination of affected lot with Parengyodontium album. - Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free... - Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) ROBOTIC recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is... recall (Diagnostica Stago, Inc.)
Medical deviceClass IIReported January 21, 2026 · Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. - Brand Name: PALACOS Product Name: PALACOS MV pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported January 21, 2026 · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an... - Brand Name: PALACOS Product Name: PALACOS MV+G pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported January 21, 2026 · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an... - Brand Name: PALACOS Product Name: PALACOS R+G pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported January 21, 2026 · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an... - Brand Name: PALACOS Product Name: PALACOS R pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported January 21, 2026 · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an... - Philips Azurion Systems R3.0. Includes the following label descriptions and... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on... - MOSAIQ Oncology Information System with Particle Therapy License recall (Elekta, Inc.)
Medical deviceClass IIReported January 21, 2026 · Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one... - Allura Xper FD20/20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 OR Table recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 Biplane recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 Biplane recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10F recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Product Name: Allura Xper FD10C recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - BD Ready-to-Use Hydrophilic Catheter 14 Fr recall (HANGZHOU BEVER MEDICAL DEVICES CO., LTD.)
Medical deviceClass IIReported January 21, 2026 · Labeling error, Incorrect expiration date - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check... - Ivenix Infusion System recall (Fresenius Kabi USA, LLC)
Medical deviceClass IIReported January 21, 2026 · Emphasizing instructions for LVP duration programming located in the IFU. - MAXXUS recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)
Medical deviceClass IIReported January 21, 2026 · 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 ... - SMV BodyTrack recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)
Medical deviceClass IIReported January 21, 2026 · 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 ... - SMV DSI recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)
Medical deviceClass IIReported January 21, 2026 · 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 ... - SMV DSX New Line recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)
Medical deviceClass IIReported January 21, 2026 · 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 ... - A71200 Vanta" Clinician Programmer Application recall (Medtronic Neuromodulation)
Medical deviceClass IIReported January 21, 2026 · Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. - Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter recall (Boston Scientific Corporation)
Medical deviceClass IIReported January 21, 2026 · Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation... - Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography recall (Mobius Imaging, LLC)
Medical deviceClass IIReported January 21, 2026 · AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. - Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography recall (Mobius Imaging, LLC)
Medical deviceClass IIReported January 21, 2026 · AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. - MAVERICK¿ Measurement Module Spectrometer PN 820-01367 recall (REPLIGEN CORPORATION)
Medical deviceClass IIReported January 21, 2026 · Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one... - FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle... recall (Abbott Diabetes Care, Inc.)
Medical deviceClass IReported January 21, 2026 · Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results - FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle... recall (Abbott Diabetes Care, Inc.)
Medical deviceClass IReported January 21, 2026 · Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results - FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle... recall (Abbott Diabetes Care, Inc.)
Medical deviceClass IReported January 21, 2026 · Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results - FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre... recall (Abbott Diabetes Care, Inc.)
Medical deviceClass IReported January 21, 2026 · Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results - VANTAGE TITAN 3T Model MRT-3010/MEXL-3010 recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported January 21, 2026 · 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... - VANTAGE GALAN 3T Model MRT-3020/MEXL-3020 recall (Canon Medical System, USA, INC.)
Medical deviceClass IIReported January 21, 2026 · 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... - Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink... recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported January 14, 2026 · Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. - Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN... recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported January 14, 2026 · Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. - Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK recall (Medline Industries, LP)
Medical deviceClass IIReported January 14, 2026 · Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient... - Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number:... recall (IMRIS Imaging Inc)
Medical deviceClass IIReported January 14, 2026 · Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays... - Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. recall (Philips North America Llc)
Medical deviceClass IIReported January 14, 2026 · 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... - Arial 900 MHz Call Station recall (Securitas Healthcare LLC)
Medical deviceClass IIReported January 14, 2026 · 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)... - Arial 900 MHz Call Station recall (Securitas Healthcare LLC)
Medical deviceClass IIReported January 14, 2026 · 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)... - Impella 5.5 with SmartAssist¿ S2 recall (Abiomed, Inc.)
Medical deviceClass IIReported January 14, 2026 · Device packaged in incorrect outer box carton. - The Pressio 2 ICP Monitoring System recall (Sophysa)
Medical deviceClass IIReported January 14, 2026 · Customer complaints of Pressio monitor rebooting. - BD Pyxis ES Enterprise Server Catalog Numbers 1115-00 recall (CareFusion 303, Inc.)
Medical deviceClass IIReported January 14, 2026 · Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. - Philips Tempus Pro Patient Monitor recall (Remote Diagnostic Technologies Ltd.)
Medical deviceClass IIReported January 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... - Beckman Coulter UniCel Dxl 800 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported January 14, 2026 · Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard... - Beckman Coulter UniCel Dxl 600 recall (Beckman Coulter, Inc.)
Medical deviceClass IIReported January 14, 2026 · Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard... - Revogene C. difficile recall (Meridian Bioscience Inc)
Medical deviceClass IIReported January 14, 2026 · The affected lots show a decline in performance over time, which may lead to false-negative results. - Kii Low Profile recall (Applied Medical Resources Corp)
Medical deviceClass IIReported January 14, 2026 · There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing. - The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with... recall (Roche Diagnostics Operations, Inc.)
Medical deviceClass IIReported January 14, 2026 · Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as... - Philips Incisive CT recall (Philips Healthcare (Suzhou) Co., Ltd.)
Medical deviceClass IIReported January 14, 2026 · Potential for incomplete scan due to unstable connection inside of floating sensor. - LUMINOS Lotus Max recall (Siemens Medical Solutions USA, Inc)
Medical deviceClass IIReported January 14, 2026 · A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and... - BVI Leos Laser and Endoscopy System. Model Number: OME6000U. recall (Beaver-Visitec International, Inc.)
Medical deviceClass IIReported January 7, 2026 · Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not... - Sheathes3D Seamless Viral Barrier recall (Sheathing Technologies Inc)
Medical deviceClass IIReported January 7, 2026 · Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. - Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog... recall (Ferndale Laboratories, Inc.)
Medical deviceClass IIReported January 7, 2026 · Butyrate tube cracks during actuation, rendering product unusable. - Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe recall (Vortex Surgical Inc.)
Medical deviceClass IIReported January 7, 2026 · Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly. - Restore Clinician Programmer Application recall (Medtronic Neuromodulation)
Medical deviceClass IIReported December 31, 2025 · Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and... - R¿sch-Uchida Transjugular Liver Access Sets recall (Cook Incorporated)
Medical deviceClass IIReported December 31, 2025 · Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut... - Ring Transjugular Intrahepatic Access Sets recall (Cook Incorporated)
Medical deviceClass IIReported December 31, 2025 · Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut... - Flexor Check-Flo Introducers and Sets recall (Cook Incorporated)
Medical deviceClass IIReported December 31, 2025 · Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut...