Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Exploro Highly Sensitive Male Fertility / Sperm Concentration 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 pTau217/B-Amyloid 1-42 Plasma Ratio 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).
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Uri...
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.
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Materi...
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.
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With...
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
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: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Singl...
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo...
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
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.
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-...
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or ...
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca...
Devices which did not undergo thermoforming could deform and lose performance.
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Wi...
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Conv...
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.
Male Fertility Sperm Test for Home Use (Cassette)
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.
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile...
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: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/...
Devices which did not undergo thermoforming could deform and lose performance.
25GA Subretinal Injection Cannula VS0220.25
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.
SOMATOM X.ceed 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.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411...
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V43...
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 Model/Catalog Number: KD-V411...
Devices which did not undergo thermoforming could deform and lose performance.