Medical Device Recalls
The most recent FDA medical-device recalls affecting healthcare technology, gathered from the openFDA device enforcement database.
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patien
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depr
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of me
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of me
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of me
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier pac
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Potential for breach in sterile barrier of device packaging.
Potential for breach in sterile barrier of device packaging.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Potential for breach in sterile barrier of device packaging.
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifo
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Class IIIOut-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the o
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Class IIIout-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not imp
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ve
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient rec