February 5, 2025Medical DevicesFDA
SIEMENS MEDICAL SOLUTIONS USA, INC recalls ARTIS One Angiographic X-Ray System
Hazard: A potential issue with ARTIS One systems was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose-rate may be higher than intended by the user.
January 29, 2025Medical DevicesFDA
Randox Laboratories, Limited recalls Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalo
Hazard: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
January 29, 2025Medical DevicesFDA
Randox Laboratories, Limited recalls Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catal
Hazard: Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.
January 29, 2025Medical DevicesFDA
Trinity Sterile, Inc. recalls Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Versi
Hazard: Potential for hole in package compromising sterility of the medical kit.
January 29, 2025Medical DevicesFDA
Trinity Sterile, Inc. recalls Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC
Hazard: Potential for hole in package compromising sterility of the medical kit.
January 29, 2025Medical DevicesFDA
Trinity Sterile, Inc. recalls Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicato
Hazard: Potential for hole in package compromising sterility of the medical kit.
January 29, 2025Medical DevicesFDA
Trinity Sterile, Inc. recalls Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 M
Hazard: Potential for hole in package compromising sterility of the medical kit.
January 29, 2025Medical DevicesFDA
Trinity Sterile, Inc. recalls Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46
Hazard: Potential for hole in package compromising sterility of the medical kit.
January 29, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Hazard: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
January 29, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538
Hazard: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
January 29, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Hazard: Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
January 29, 2025Medical DevicesFDA
Integrity Implants Inc. recalls Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Descr
Hazard: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
January 29, 2025Medical DevicesFDA
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Cer
Hazard: The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
January 29, 2025Medical DevicesFDA
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certif
Hazard: The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
January 29, 2025Medical DevicesFDA
Ortho-Clinical Diagnostics, INc. recalls Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified
Hazard: The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
January 29, 2025Medical DevicesFDA
Becton Dickinson & Co. recalls BD PCR Cartridges used with MAX System. Model Number: 437519
Hazard: Potential for signal drift in specific lots of BD PCR Cartridges.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-a
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Gri
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front
Hazard: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
January 29, 2025Medical DevicesFDA
MICROVENTION INC. recalls Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On
Hazard: Sterility assurance; microcatheter inner packaging may contain incomplete seal.
January 29, 2025Medical DevicesFDA
St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.n
Hazard: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.
January 29, 2025Medical DevicesFDA
St. Jude Medical recalls CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.ne
Hazard: As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) reverted to an outdated configuration causing incorrect/inaccurate pulmonary artery (PA) pressure readings.