Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Vivoo Vaginal pH Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Num...
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740....
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 815...
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Vo...
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Wi...
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Vivoo pH Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca...
Devices which did not undergo thermoforming could deform and lose performance.
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Tri...
Devices which did not undergo thermoforming could deform and lose performance.
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT ...
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; L...
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4...
Devices which did not undergo thermoforming could deform and lose performance.
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M...
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M1...
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material...
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275....
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411...
Devices which did not undergo thermoforming could deform and lose performance.
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sea...
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4...
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4...
Devices which did not undergo thermoforming could deform and lose performance.
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Lase...
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vivoo Protein Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.