Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

1101–1125 of 13399

HighFDA (Devices)·Z-1136-2026·2026-01-28
TS-10 and TS-10H Tube Sorters recalled due to lift disengagement risk
Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters nationwide due to a mechanical defect where the electromagnetic holding force may disengage unexpectedly, causing the lift to drop.
Product
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1129-2026·2026-01-28
Allwell Angioplasty Pack inflation device handle may detach during procedure
Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during procedure.
Product
Allwell Angioplasty Pack REF: IS-30-B1/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1150-2026·2026-01-28
EDAN Central Monitoring System medical device recall for cybersecurity issues
Edan Diagnostics is recalling the EDAN Central Monitoring System due to potential cybersecurity issues identified by the FDA. The system manages information from EDAN medical devices.
Product
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring info
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1156-2026·2026-01-28
Medical Device Software Update Silently Changes Alert Settings Without User Notification
A software update to Philips Patient Information Center iX modifies Mobile Event Notification filter settings without alerting users during upgrade. This could result in missed critical patient alerts to medical staff.
Product
Patient Information Center iX; Software Version Number: 4.5.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1148-2026·2026-01-28
EDAN Patient Monitor Models Recalled Due to Potential Cybersecurity Vulnerabilities
Edan Diagnostics is recalling EDAN patient monitors (X8, X10, X12 models) due to potential cybersecurity issues identified in an FDA letter. Approximately 3,824 units were distributed worldwide.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1131-2026·2026-01-28
VOLT Wrist System Surgical Plate Recalled Due to Incorrect Thread Orientation
Tyber Medical is recalling a distal radius surgical plate due to incorrect thread orientation in anatomical left plates. This manufacturing defect may affect proper placement or stability of the implant.
Product
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1122-2026·2026-01-28
Mazor X Robotic Guidance System Recalled for Software Positioning Errors
Mazor Robotics is recalling the Mazor X robotic guidance system due to software errors that can cause incorrect surgical instrument positioning during spinal surgery. The recall affects approximately 549 systems distributed worldwide.
Product
Mazor X robotic guidance system REF: TPL0059
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2026·2026-01-28
LDL-Cholesterol Assay Performance Deviation Due to Triglyceride Interference
Beckman Coulter is recalling LDL-Cholesterol assay reagent that shows clinically significant interference from high triglyceride levels, causing measurement bias up to 28.8% in low samples and 11.02% in high samples.
Product
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a c
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1134-2026·2026-01-28
Ion Vision Probe Bag Recalled for Compromised Sterile Seals
Intuitive Surgical recalls 110,580 Ion Vision Probe Bags that may have compromised or incomplete sterile seals. Non-sterile devices used in surgical procedures could pose an infection risk.
Product
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1138-2026·2026-01-28
Rifton Low Base TRAM Patient Lift Device Recalled for Body Support Strap Fraying
Rifton Equipment is recalling approximately 1,096 Low Base TRAM powered lift devices (Model K320) due to potential fraying of the body support strap. The affected devices were distributed worldwide.
Product
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1147-2026·2026-01-28
EDAN iM20 Patient Monitor recalled due to potential cybersecurity issues
Edan Diagnostics is recalling approximately 377 EDAN iM20 Patient Monitors due to potential cybersecurity vulnerabilities identified by the FDA. No injuries have been reported.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-inv
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1157-2026·2026-01-28
Blood Transfusion Filter Recall Due to Unconfirmed Sterility
GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters because they were released before completing required quality control testing. Sterility assurance cannot be confirmed.
Product
SQ40S Blood Transfusion Filter
Category
Medical Device
Distribution
28 states
HighFDA (Devices)·Z-1125-2026·2026-01-28
Merit Medical Vascular Waste Kit Inflation Handle May Detach During Procedure
Merit Medical Custom Waste Management Kit Vascular Tray inflation device handles may detach from syringes during medical procedures. This Class II recall affects 864 units distributed worldwide.
Product
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1140-2026·2026-01-28
EDAN Fetal Monitors F2 and F3 Recalled for Cybersecurity Vulnerabilities
Edan Diagnostics recalls EDAN fetal monitor models F2 and F3 due to potential cybersecurity issues identified by the FDA. No injuries or illnesses have been reported.
Product
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1106-2026·2026-01-28
RayStation Radiation Therapy Treatment Planning System Dose Invalidation Error Recall
RayStation radiation therapy treatment planning software (versions 14.0.0, 15.0.0, and 15.1.3) may fail to properly invalidate calculated radiation doses for certain region types. This could result in use of outdated dose calculations in patient treatment planning.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1153-2026·2026-01-28
EDAN Vital Signs Monitor recalled for potential cybersecurity vulnerabilities
Edan Diagnostics is recalling EDAN Vital Signs Monitor Model M3A devices due to potential cybersecurity vulnerabilities identified by the FDA.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1151-2026·2026-01-28
EDAN Central Monitoring System Recalled for Potential Cybersecurity Vulnerabilities
EDAN Diagnostics is recalling 395 units of its MFM-CNS and MFM-CNS Lite central monitoring systems following an FDA letter regarding potential cybersecurity issues.
Product
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1110-2026·2026-01-28
RayStation radiation therapy treatment planning software dose invalidation defect
RayStation v17.0.0 and v17.0.1 fail to properly invalidate dose calculations for certain regions of interest. The system may not recalculate radiation doses when geometry changes or material overrides are removed.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1155-2026·2026-01-28
EDAN iT20 Telemetry Transmitter Recalled Due to Cybersecurity Vulnerabilities
The FDA has recalled the EDAN iT20 Telemetry Transmitter due to potential cybersecurity vulnerabilities. Approximately 1,457 units were distributed across the United States and Mexico.
Product
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The para
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1113-2026·2026-01-28
Philips Azurion X-Ray System Recalled for Software Malfunction Issues
Philips has recalled the Azurion imaging system (Software Version R3.1) in 228 units worldwide due to two software issues that may cause loss of imaging functionality, motorized movement, incorrect image content, or data loss.
Product
Philips Azurion system; Software Version Number: R3.1;
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1123-2026·2026-01-28
Merit Medical Inflation Device Handle May Detach During Procedures
Merit Medical Systems is recalling inflation device units because the handle may detach from the syringe during medical procedures. Affected units: 4,163,123 worldwide.
Product
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2026·2026-01-28
Radiation Therapy Planning Software May Not Recalculate Doses When Regions Are Modified
RayStation radiation therapy planning software may fail to invalidate radiation dose calculations when certain regions of interest are modified. This could cause patients to be treated using outdated or incorrect dose values.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1111-2026·2026-01-28
Tego Needle-Free Connectors Recalled for Silicone Seal Separation Risk
ICU Medical is recalling Tego needle-free connectors used in hemodialysis and IV administration because the silicone seal may separate or tear, potentially causing fluid leaks, therapy delays, or exposure to harmful contaminants.
Product
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1142-2026·2026-01-28
EDAN Vital Signs Monitor M3 Recalled Due to Cybersecurity Vulnerability
Edan Diagnostics is recalling the EDAN Vital Signs Monitor Model M3 following an FDA letter regarding potential cybersecurity issues. Approximately 13,934 units were distributed in 14 U.S. states and Mexico.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-inv
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1108-2026·2026-01-28
Radiation Therapy Treatment Planning Software Dose Invalidation Bug
RayStation radiation therapy software may fail to invalidate calculated doses in certain cases. The issue affects Regions of Interest without contours that have material overrides or specific types.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states

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