Category
FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Boston Scientific is recalling 588 units of HOT AXIOS biliary stents worldwide due to reports of deployment and expansion failures that may require additional endoscopic or surgical intervention.
FDA Class I recall of AXIOS Stents due to reported deployment and expansion failures. Affected patients may require device exchange or additional surgical intervention to remove the stent and close the puncture site.
Boston Scientific is recalling 266 units of the HOT AXIOS Stent due to deployment and expansion issues that may require additional surgical intervention to remove the stent and close the puncture site.
Boston Scientific recalls HOT AXIOS 8mm stent delivery system for deployment and expansion failures. The devices may require surgical intervention to remove the stent and close puncture sites.
Fujirebio Diagnostics is recalling Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results that could incorrectly classify patients as having or not having Alzheimer's amyloid pathology.
Olympus recalls Disposable Triple Lumen Sphincterotome Model KD-401Q-0720 devices due to manufacturing defects that could cause device deformation and loss of performance during medical procedures.
Olympus is recalling 887 units of the Disposable Triple Lumen Sphincterotome due to a manufacturing defect. Devices that did not undergo thermoforming could deform and lose performance during use.
Beckman Coulter is recalling specific lots of COULTER DxH Diluent due to elevated background counts in platelet Daily Checks when used with UniCel DxH analyzers. This can affect test result accuracy.
Focalyx Fusion prostate imaging devices may not work properly on Windows 10, risking patient harm during biopsy or treatment delays. The manufacturer recommends stopping use until Windows 11 compatibility is verified.
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST100 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.
Olympus is recalling approximately 11,779 Single Use 3-Lumen Sphincterotome V surgical instruments distributed in the US. Some devices may not have undergone proper thermoforming, which could cause them to deform and lose performance during use.
Vivoo Protein Test strips were distributed without FDA clearance. The unapproved devices may produce false or inaccurate diagnostic results, potentially leading to inappropriate medical treatment.
Electromagnetic contactors in FDR Visionary Suite X-ray generator cabinets may stay powered after shutdown, risking overheating and fire. 16 units affected in eight US states.
Olympus is recalling 4,183 Single Use 3-Lumen Sphincterotome V devices because some units did not undergo thermoforming, which could cause deformation and loss of performance.
Olympus recalls approximately 125 units of the Disposable Triple Lumen Sphincterotome (Model KD-411Q-0720) worldwide due to thermoforming defects that could cause device deformation and loss of performance.
Vortex Surgical is recalling its I2 Injection Kits (model VS0500) due to potential voids in pouch seals that could compromise the sterile barrier and cause infection. Affected are 14,789 units distributed nationwide and internationally.
Olympus Corporation recalls 93 Single-Use 3-Lumen Sphincterotome V devices due to improper thermoforming that may cause deformation and performance loss. Affected devices were distributed nationwide and internationally.
VANTIVE US HEALTHCARE is recalling 13,760 PRISMAFLEX TPE2000 dialyzer sets nationwide due to potential dislodgement of the deaeration chamber from the control unit.
Olympus Corporation is recalling 10,257 units of Single Use 3-Lumen Sphincterotome V endoscopic instruments. Some devices did not undergo thermoforming during manufacturing and could deform and lose performance.
Olympus Corporation is recalling the Single Use 3-Lumen Sphincterotome V surgical device due to a manufacturing defect where some devices may not have undergone proper thermoforming, potentially causing deformation and performance loss during surgical procedures.
Vantive US Healthcare is recalling the Prismaflex HF1000 SET dialyzer due to a potential dislodgement of the deaeration chamber from the control unit. The recall affects 93,576 units distributed nationwide.
Encore Medical recalled EMPOWR 3D Knee Tibial Insert devices and other orthopedic implants due to packaging discrepancies that may deliver wrong devices, potentially requiring surgical delay or revision procedures.
Multiple brands of UTI test strips have been recalled for distribution before FDA clearance. The strips may produce false or inaccurate results that could lead to inappropriate medical decisions.
Siemens is removing three software applications from SOMATOM X.ceed CT systems worldwide because they lack FDA 510(k) clearance. Affected units are being recalled to ensure regulatory compliance.
Olympus Corporation is recalling the KD-640L electrosurgical knife nationwide due to deterioration causing overheating, burning, and tip breakage risk during surgery.
Looking for a different category? Browse all recalls.