Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 3,901–3,950 of 8,689

Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Class II
Medical Device Recall · May 21, 2025
BIGFOOT BIOMEDICAL
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Conf
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.
Class II
Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Class II
Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Class II
Medical Device Recall · May 21, 2025
Covidien
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
Class I
Medical Device Recall · May 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Class II
Medical Device Recall · May 21, 2025
Diagnostica Stago, Inc.
STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
Class II
Medical Device Recall · May 20, 2025
Geneoscopy, Inc.
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
Class II
Medical Device Recall · May 20, 2025
Onkos Surgical, Inc.
My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device
Required inspections were not performed on finished product prior to release and distribution.
Class II
Medical Device Recall · May 20, 2025
Becton Dickinson & Co.
BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
Class II
Medical Device Recall · May 19, 2025
Limacorporate S.p.A
PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Class II
Medical Device Recall · May 19, 2025
Neurovision Medical Products Inc
Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ;
Product packaging contains the wrong part number and kit contents.
Class II
Medical Device Recall · May 19, 2025
Limacorporate S.p.A
PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Class II
Medical Device Recall · May 16, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
Class II
Medical Device Recall · May 16, 2025
GE Medical Systems China Co., Ltd.
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
Class II
Medical Device Recall · May 16, 2025
Drs Vascular, Inc
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use
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Class II
Medical Device Recall · May 16, 2025
THERAKOS DEVELOPMENT LIMITED
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracor
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
Class II
Medical Device Recall · May 15, 2025
Contamac Solutions, Inc.
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Contact lens insertion solution may lack sterility.
Class II
Medical Device Recall · May 15, 2025
Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II
Medical Device Recall · May 15, 2025
Siemens Medical Solutions USA, Inc
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Proc
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II
Medical Device Recall · May 15, 2025
Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II
Medical Device Recall · May 15, 2025
Siemens Medical Solutions USA, Inc
interventional fluoroscopic x-ray system
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Class II
Medical Device Recall · May 15, 2025
Cook Incorporated
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft len
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Class I
Medical Device Recall · May 15, 2025
SunMed Holdings, LLC
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based re
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
Class I
Medical Device Recall · May 15, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Class II
Medical Device Recall · May 14, 2025
Edwards Lifesciences, LLC
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class I
Medical Device Recall · May 14, 2025
Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class I
Medical Device Recall · May 14, 2025
Edwards Lifesciences, LLC
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class I
Medical Device Recall · May 14, 2025
Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class I
Medical Device Recall · May 14, 2025
Edwards Lifesciences, LLC
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class I
Medical Device Recall · May 14, 2025
Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Class I
Medical Device Recall · May 13, 2025
Cardinal Health 200, LLC
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Cardinal Health 200, LLC
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Belmont Instrument LLC
Allon 2001. Part Number: 200-00263
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Cardinal Health 200, LLC
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia 1.5T S; Model Number: 781347;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Upgrade to MR 7700; Model Number: 782130;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II
Medical Device Recall · May 13, 2025
Spectral Instruments Inc
Lago X
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
Class II
Medical Device Recall · May 13, 2025
Philips North America Llc
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Class II