Medical Devices Recalls

Hazard: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Hazard: Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

Hazard: Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.

Hazard: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Hazard: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Hazard: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Hazard: Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

Hazard: This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.

Hazard: out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Hazard: Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.

Hazard: Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

Hazard: A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).

Hazard: Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

Hazard: 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 after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

Hazard: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

Hazard: Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.

Hazard: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Hazard: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Hazard: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Hazard: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Hazard: Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.

Hazard: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Hazard: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Hazard: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Hazard: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Hazard: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

Hazard: Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Hazard: Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.

Hazard: Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.

Hazard: Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.