July 16, 2025Medical DevicesFDA
Medtronic Navigation, Inc.-Boxborough recalls O-arm O2 Imaging System. Mobile X-Ray System.
Hazard: A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
July 16, 2025Medical DevicesFDA
Neurovision Medical Products Inc recalls Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Si
Hazard: Product packaging contains the wrong part number and kit contents.
July 16, 2025Medical DevicesFDA
Canary Medical, Inc. recalls Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Descript
Hazard: Due to labeling error. Product incorrectly labeled.
July 16, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Hazard: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
July 16, 2025Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Hazard: Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
July 16, 2025Medical DevicesFDA
STRATASYS LTD recalls TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental a
Hazard: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
July 16, 2025Medical DevicesFDA
STRATASYS LTD recalls TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental
Hazard: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
July 16, 2025Medical DevicesFDA
STRATASYS LTD recalls TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental
Hazard: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
July 16, 2025Medical DevicesFDA
STRATASYS LTD recalls TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental a
Hazard: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
July 16, 2025Medical DevicesFDA
STRATASYS LTD recalls TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental
Hazard: Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software V
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Edwards Lifesciences, LLC recalls Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software V
Hazard: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
July 16, 2025Medical DevicesFDA
Given Imaging Ltd. recalls Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic
Hazard: It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
July 16, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoSc
Hazard: The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
July 16, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile
Hazard: The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
July 9, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Hazard: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
July 9, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Hazard: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
July 9, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Hazard: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
July 9, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i SETpoint Calibrator
Hazard: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
July 9, 2025Medical DevicesFDA
Becton, Dickinson and Company, BD Bio Sciences recalls REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Hazard: Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
July 9, 2025Medical DevicesFDA
Becton, Dickinson and Company, BD Bio Sciences recalls REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence com
Hazard: Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
July 9, 2025Medical DevicesFDA
Geneoscopy, Inc. recalls ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Hazard: 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.
July 9, 2025Medical DevicesFDA
C.R. Bard Inc recalls REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Hazard: Cather packaging may contain the incorrect French size.
July 9, 2025Medical DevicesFDA
C.R. Bard Inc recalls BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Hazard: Cather packaging may contain the incorrect French size.
July 9, 2025Medical DevicesFDA
C.R. Bard Inc recalls BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr
Hazard: Cather packaging may contain the incorrect French size.
July 9, 2025Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package c
Hazard: Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.