August 28, 2024Medical DevicesFDA
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients wit
Hazard: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
August 28, 2024Medical DevicesFDA
Beckman Coulter Mishima K.K. recalls DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl
Hazard: Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
August 28, 2024Medical DevicesFDA
Stryker Sustainability Solutions recalls Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Hazard: Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
August 28, 2024Medical DevicesFDA
Intrinsic Therapeutics, Inc. recalls Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Hazard: At least two units have been found to be missing a weld.
August 28, 2024Medical DevicesFDA
Preat Corp recalls Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straum
Hazard: Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
August 28, 2024Medical DevicesFDA
Becton Dickinson & Co. recalls BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from c
Hazard: May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
August 28, 2024Medical DevicesFDA
ROi CPS LLC recalls Regard Kit containing the Microtek decanter
Hazard: Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
August 28, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein
Hazard: The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.
August 28, 2024Medical DevicesFDA
BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Hazard: Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
August 28, 2024Medical DevicesFDA
BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Hazard: Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
August 28, 2024Medical DevicesFDA
Abbott Laboratories recalls Alinity hq Analyzer, REF: 09P68-01
Hazard: 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Componen
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component:
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version:
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version:
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version:
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version:
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version:
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version:
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Produ
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Produ
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
August 28, 2024Medical DevicesFDA
Alcon Research LLC recalls Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Produ
Hazard: Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.