Medical device recalls

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

1126–1150 of 13399

HighFDA (Devices)·Z-1109-2026·2026-01-28
RayStation radiation therapy planning system dose invalidation software defect
RayStation treatment planning system version 16.0.0 has a software defect preventing dose recalculation for certain region of interest configurations. The defect affects dose invalidation when specific ROI types lack contours combined with material overrides or bolus classifications.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1124-2026·2026-01-28
Angiographic Inflation Device Handle May Detach During Procedures
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device (Model IS-30-A) due to risk that the handle may detach from the syringe during angiographic procedures.
Product
Allwell Inflation Device, for angiographic use REF: IS-30-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1149-2026·2026-01-28
EDAN Patient Monitors Recalled for Cybersecurity Vulnerabilities
Edan Diagnostics is recalling EDAN iX series patient monitors (models iX10, iX12, iX15) due to potential cybersecurity vulnerabilities identified by the FDA.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 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-1152-2026·2026-01-28
EDAN M3B Vital Signs Monitor Recalled for Potential Cybersecurity Issues
The FDA is recalling EDAN M3B Vital Signs Monitors due to potential cybersecurity vulnerabilities. Approximately 354 units were distributed in hospitals across the U.S. and Mexico.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1133-2026·2026-01-28
MicroPort hip trial component recalled for missing FDA authorization
MicroPort Orthopedics is recalling its HIPTURN FEM HEAD TRIAL 36MM REUSABLE hip trial component due to distribution without FDA premarket authorization required in the United States.
Product
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1102-2026·2026-01-28
Radiation Therapy Planning Software Dose Calculation Error in RayStation
RayStation radiation therapy planning software version 10.1 may fail to properly invalidate radiation dose calculations when regions of interest lack contours but have material overrides or are bolus/fixation/support types.
Product
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1141-2026·2026-01-28
FDA Recalls EDAN Fetal and Maternal Monitors for Cybersecurity Issues
Edan Diagnostics is recalling EDAN fetal and maternal monitors (models F6, F9, F6 Express, F9 Express) affecting 3,518 units due to potential cybersecurity vulnerabilities.
Product
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1145-2026·2026-01-28
EDAN Patient Monitors Recalled Due to Potential Cybersecurity Vulnerabilities
EDAN patient monitors (models iM50, iM60, iM70, iM80) are being recalled for potential cybersecurity vulnerabilities identified by the FDA.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capa
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1112-2026·2026-01-28
GE Healthcare Omni Legend PET Systems Streaking Artifact Recall
GE Healthcare Omni Legend PET systems may produce intermittent streaking artifacts in clinical scan images visible on the acquisition console. Approximately 364 units are affected worldwide.
Product
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1154-2026·2026-01-28
EDAN iM8 Series Patient Monitors Recalled for Potential Cybersecurity Vulnerabilities
FDA has issued a recall for EDAN iM8 series patient monitors due to potential cybersecurity vulnerabilities identified in an IHCTOA letter. Approximately 3,141 units are affected across multiple U.S. states and Mexico.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and cont
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1137-2026·2026-01-28
Rifton TRAM Powered Lift Device Recalled for Fraying Body Support Strap
Community Products recalls the Rifton TRAM (Model K310) powered lift device due to potential fraying on the body support strap. Approximately 3,238 units were distributed worldwide.
Product
Rifton Equipment, TRAM. Model/Catalog Number: K310. 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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1146-2026·2026-01-28
EDAN elite Patient Monitors Recalled for Cybersecurity Vulnerabilities
Edan Diagnostics is recalling EDAN elite patient monitors (V5, V6, V8 models) due to potential cybersecurity vulnerabilities. Approximately 342 units have been distributed across the United States and Mexico.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Als
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1119-2026·2026-01-28
ICU Medical Plum IV Pump software blocks programming of therapeutic flush
ICU Medical Plum Solo and Duo Infusion Pumps may prevent programming of a flush feature after piggyback therapy due to software limit errors. Error messages block this intended pump function.
Product
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1020-2026·2026-01-21
FreeStyle Libre 3 Sensor Recall Due to Incorrect Glucose Reading Risk
Abbott recalls approximately 1.06 million FreeStyle Libre 3 sensors due to a manufacturing defect causing carbon buildup that may produce incorrect low glucose readings, potentially affecting diabetes management.
Product
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
SevereFDA (Devices)·Z-1021-2026·2026-01-21
FreeStyle Libre 3 Plus Sensor recalled for manufacturing defect causing inaccurate glucose readings
Abbott's FreeStyle Libre 3 Plus Sensor is being recalled due to a manufacturing issue that may cause carbon buildup in the sensor, potentially resulting in incorrect low glucose readings.
Product
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
SevereFDA (Devices)·Z-1023-2026·2026-01-21
FreeStyle Libre 3 Plus Sensor Recalled for Incorrect Glucose Readings
Abbott Diabetes Care is recalling 8,062 FreeStyle Libre 3 Plus sensors due to a manufacturing defect that may cause carbon buildup, resulting in incorrect low glucose readings.
Product
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
SevereFDA (Devices)·Z-1022-2026·2026-01-21
FreeStyle Libre 3 Plus Sensor Recall: Potential Incorrect Low Glucose Readings
Abbott is recalling approximately 258,913 FreeStyle Libre 3 Plus Sensors due to carbon buildup that may cause incorrect low glucose readings. The affected sensors expire on 01/31/2026.
Product
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-1075-2026·2026-01-21
Allura Xper FD20 X-ray system cooling unit drip tray installation issue
Two Philips Allura Xper FD20 X-ray systems may lack proper installation of the cooling unit drip tray, risking coolant leakage onto electrical components and potential equipment shutdown.
Product
Allura Xper FD20; Model Number: 722028;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2026·2026-01-21
Philips Allura medical imaging system cooling unit installation defect
Philips is recalling 22 Allura Xper imaging systems because the drip tray beneath the cooling unit may not be installed or properly documented. Without it, coolant could contact electrical components and cause system shutdown.
Product
Allura Xper FD10/10; Model Number: 722027;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1089-2026·2026-01-21
Medline surgical procedure kits with Strykeflow suction irrigators may leak
Medline medical procedure kits containing Stryker Strykeflow 2 suction irrigators are being recalled due to a 2024 design change. Irrigation solution can travel to the handpiece and battery pack, causing leaks and vaporized saline emission resembling smoke.
Product
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1057-2026·2026-01-21
Medline Pre-Operative Kits Recalled Due to Stuck Check Valves
Medline Industries recalls pre-operative kits containing B. Braun IV administration sets because their check valve components may become stuck in open or closed positions, potentially affecting fluid delivery.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) PRE OP KIT, Medline kit SKU DYKS1124C; 3) PRE OP KIT, Medline kit SKU DYKS1128C; 4) PREOP KIT, Medline kit SKU DYKS1130B; 5) P
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2026·2026-01-21
Medical imaging system cooling component defect poses electrical hazard
Certain Philips Allura Xper diagnostic imaging systems may be missing a cooling unit drip tray, which could allow coolant to contact electrical components and trigger system shutdown.
Product
Allura Xper FD10/10; Model Number: 722011;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1065-2026·2026-01-21
Philips Allura imaging system cooling tray installation failure poses electrical hazard
A drip tray beneath the cooling unit in some Philips Allura imaging systems was not installed or not adequately documented, potentially allowing coolant to contact electrical components and cause system shutdown.
Product
Allura Xper FD10/10; Model Number: 722005;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1086-2026·2026-01-21
Medline surgical kits recalled for leaking irrigation solution during procedures
Medline medical procedure kits containing Stryker Strykeflow 2 suction irrigators are recalled. A 2024 design change causes irrigation solution to leak and vaporized saline to emit during use.
Product
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2026·2026-01-21
Asserachrom HPIA Diagnostic Test Kit Recalled Due to Potential Defect
Diagnostica Stago is recalling Asserachrom HPIA diagnostic test kits (lot 271288) due to a potential defect that may produce negative test results. The kits detect antibodies associated with heparin-induced thrombocytopenia.
Product
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
Category
Medical Device
Distribution
Distributed nationwide

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