Consumer Product Recalls

Hazard: 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.

Hazard: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Hazard: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Hazard: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Hazard: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Hazard: A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.

Hazard: A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.

Hazard: Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction

Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Hazard: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Hazard: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Hazard: Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: 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.

Hazard: Undeclared Milk Allergen