Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 3,151–3,200 of 7,959

Medical Device Recall · May 23, 2025
Insulet Corporation
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to downl
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.
Class II
Medical Device Recall · May 23, 2025
GE Medical Systems, LLC
Discovery MR750w 3.0T
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Class II
Medical Device Recall · May 23, 2025
GE Medical Systems, LLC
SIGNA PET/MR
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Class II
Medical Device Recall · May 23, 2025
Steris Corporation
Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
Class II
Medical Device Recall · May 23, 2025
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Class II
Medical Device Recall · May 23, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3)
Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Class II
Medical Device Recall · May 23, 2025
GE Medical Systems, LLC
SIGNA Architect
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Class II
Medical Device Recall · May 23, 2025
Integra LifeSciences Corp. (NeuroSciences)
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Lack of sterility assurance.
Class I
Medical Device Recall · May 23, 2025
GE Medical Systems, LLC
SIGNA Architect AIR
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Class II
Medical Device Recall · May 23, 2025
QUANTUM SURGICAL SAS
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instrument
Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.
Class II
Medical Device Recall · May 22, 2025
Siemens Healthcare Diagnostics, Inc.
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
Class II
Medical Device Recall · May 22, 2025
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemo Software
Due to complaints, software update may cause software to unexpectedly shutdown.
Class II
Medical Device Recall · May 22, 2025
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Cardiology Hemodynamics Software
Due to complaints, software update may cause software to unexpectedly shutdown.
Class II
Medical Device Recall · May 22, 2025
Stryker GmbH
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Class II
Medical Device Recall · May 22, 2025
LTS Therapy Systems, LLC
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Class II
Medical Device Recall · May 22, 2025
LTS Therapy Systems, LLC
IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Class II
Medical Device Recall · May 22, 2025
Stryker GmbH
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Class II
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 15 CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator, 8CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I
Medical Device Recall · May 22, 2025
Jewel Precision Sheet Metal & Machining Co, Inc.
Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
Class II
Medical Device Recall · May 22, 2025
Integra LifeSciences Corp. (NeuroSciences)
Extended Tip Applicator 8CM, Box of 1.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Class I
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, HT
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
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: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 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 21, 2025
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 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
Jolife AB
LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous br
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
Class II
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
Becton Dickinson Infusion Therapy Systems, Inc.
REF: 382544 BD Insyte Autoguard 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: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 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: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/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: 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
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 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
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 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
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 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
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
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