August 16, 2023Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fr
Hazard: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
August 16, 2023Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, frac
Hazard: Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexib
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexibl
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display m
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 16, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to
Hazard: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. BREA
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. EGG
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUST
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. C V
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETA
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGI
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PROB
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR M
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PREM
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CVC
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENT
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADUL
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6"
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIAT
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DR. RO
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
August 9, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54)
Hazard: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.