December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011,
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 20
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Novation Hip System, Catalog Numbers: 134-36-45
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Exactech, Inc. recalls AcuMatch Hip System, Catalog Number 142-32-27
Hazard: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
December 27, 2023Medical DevicesFDA
Philips North America Llc recalls The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross
Hazard: Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-d
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Karl Storz Endoscopy recalls Injection Needle, REF: 25207
Hazard: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
December 27, 2023Medical DevicesFDA
Biomet, Inc. recalls Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Hazard: One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
December 27, 2023Medical DevicesFDA
Biomet, Inc. recalls Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
Hazard: One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
December 27, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loo
Hazard: Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
December 27, 2023Medical DevicesFDA
Physio-Control, Inc. recalls AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Hazard: AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
December 27, 2023Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Hazard: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
December 27, 2023Medical DevicesFDA
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Hazard: There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
December 27, 2023Medical DevicesFDA
Vero Biotech, LLC recalls VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric o
Hazard: Cassette did not meet an 1n-process flow criterion.
December 27, 2023Medical DevicesFDA
Inpeco S.A. recalls Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to au
Hazard: Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
December 27, 2023Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion
Hazard: Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
December 27, 2023Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006
Hazard: Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
December 27, 2023Medical DevicesFDA
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Hazard: The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirFit F30i Full Face Mask and User Guide
Hazard: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirFit F30 Full Face Mask and User Guide
Hazard: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirTouch N20 Nasal Mask and User Guide
Hazard: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirFit N20 Nasal Mask and User Guide
Hazard: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
December 27, 2023Medical DevicesFDA
ResMed Ltd. recalls AirTouch F20 Full Face Mask and User Guide
Hazard: Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact