Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAM...
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: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4...
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411...
Devices which did not undergo thermoforming could deform and lose performance.
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or ...
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use a...
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 ...
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).
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use E...
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
CellMek SPS Sample Preparation System, REF: C44603, with software
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material N...
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.
Focalyx Fusion
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 S...
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).
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca...
Devices which did not undergo thermoforming could deform and lose performance.
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illu...
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.
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Mat...
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.
S. Typhi/Para Typhi A Antigen
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.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41...
Devices which did not undergo thermoforming could deform and lose performance.
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
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Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
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 (Distal Wire guided) Model/Ca...
Devices which did not undergo thermoforming could deform and lose performance.
Tecfen Retractable Membrane Polisher, QTPR1267-23
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-V41...
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.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca...
Devices which did not undergo thermoforming could deform and lose performance.