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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Diagnostic test strips for S. Typhi and Para Typhi A antigens were distributed without FDA approval and may provide inaccurate results, potentially leading to inappropriate medical intervention.
VANTIVE US Healthcare is recalling 264,040 PRISMAFLEX ST150 dialyzers nationwide due to potential dislodgement of the deaeration chamber from the control unit during use.
Olympus is recalling its KD-645 electrosurgical knife due to deterioration of the cutting knife that can cause overheating, burning, and tip breakage during endoscopic surgery. A total of 3,361 units have been distributed nationwide.
Fujirebio Diagnostics is recalling the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio diagnostic test because it may produce falsely elevated positive or indeterminate results, causing patients to be incorrectly classified as having Alzheimer's disease or requiring unnecessary further testing.
Fujirebio Diagnostics is recalling Lumipulse β-Amyloid Plasma Controls due to falsely elevated test results that may cause incorrect classification of Alzheimer's disease status. The quality control product may provide false positive or unnecessary indeterminate results.
Vortex Surgical is recalling Oertli laser probes due to voids in Tyvek pouches that could compromise the sterile barrier and lead to infection risk.
Vortex Surgical is recalling its 25GA Internal Delivery Device due to voids in pouch seals that may compromise sterility, allowing potential bacterial contamination that could lead to infection.
FDA is recalling Lumipulse G β-Amyloid 1-42-N Plasma Immunoreaction Cartridges due to inaccurate test results that may falsely classify patients as having Alzheimer's disease pathology or requiring unnecessary clinical testing.
Siemens is recalling software applications used in NAEOTOM Alpha CT systems because they lack FDA 510(k) clearance. The recall affects 88 units.
Vortex Surgical is recalling Tecfen Retractable Membrane Polishers due to potential voids in sterile pouches that could compromise the barrier and allow bioburden contamination. Approximately 8,651 units were distributed in the US.
Three brands of urinalysis and ketone test strips have been recalled because they were distributed without required FDA approval and may produce inaccurate diagnostic results. False or incorrect readings could lead to inappropriate medical decisions.
Olympus recalls 999 units of Disposable Triple Lumen Sphincterotomes due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during use.
Vortex Surgical Inc. is recalling 25GA Subretinal Injection Cannulas due to voids in the sterile Tyvek pouches that could allow bioburden contamination and potentially lead to infection.
Vivoo pH Test strips were distributed before obtaining required FDA clearance. The devices may produce false or inaccurate results when used by consumers, potentially leading to inappropriate medical treatment.
Vortex Surgical is recalling disposable forceps and cannulas due to voids in Tyvek pouch seals that could compromise sterile barriers and allow bioburden contamination, potentially leading to infection.
A software error in the CellMek SPS Sample Preparation System causes samples to be dispensed incorrectly, resulting in sample loss of 60-100 microliters. This could lead to incorrect laboratory results and patient management decisions.
Lumipulse G plasma calibrators may produce inaccurate test results, causing false positive or indeterminate classifications for Alzheimer's disease. 128 units are affected nationwide.
Olympus is recalling its Single Use Sphincterotome V devices that may not have undergone proper thermoforming, which could cause them to deform and lose performance.
Olympus recalls single-use sphincterotomes that may deform and lose performance if not properly thermoformed during manufacturing. No injuries have been reported.
Olympus is recalling 886 units of its Disposable Triple Lumen Sphincterotome (Model KD-401Q-0330) because some devices may not have undergone proper thermoforming and could deform and lose performance during use.
Fujirebio's Lumipulse pTau 217 Plasma Controls may produce inaccurate test results, causing false positive or indeterminate readings. This could lead to incorrect Alzheimer's disease diagnosis or unnecessary clinical testing.
Molift 4-point sling bars are being recalled due to a bolt defect caused by material deformation between the lifting bar and device arm, which prevents proper device functionality.
Olympus has recalled Single Use 3-Lumen Sphincterotome V devices (Model KD-V411M-0725) worldwide because some units may not have undergone proper thermoforming, which could cause deformation and performance loss.
VANTIVE US HEALTHCARE LLC is recalling 2,724 units of OXIRIS SET dialyzers nationwide due to potential dislodgement of the deaeration chamber, which could impair device function.
Encore Medical recalls EMPOWR Acetabular System hip implant liners due to packaging errors where wrong device components were found in packaging. The discrepancy may cause surgical delay or need for revision surgery.
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