ð¥ Medical Devices ⢠6,839 recalls
Cardinal Health 200
Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Centerline Biomedical
Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.
Becton Dickinson Infusion Therapy Systems
Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
LeMaitre Vascular
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging .
Integra LifeSciences Corp. (NeuroSciences)
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Due to a potential open seal in the sterile barrier packaging .
Tornier S.A.S.
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Due to a potential open seal in the sterile barrier packaging.
Galt Medical
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging .
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.
Olympus Corporation of the Americas
Preset treatment parameters are not consistently being used in accordance with the IFU.
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.