August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Out
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Merit Medical Systems, Inc. recalls Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rap
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
August 21, 2024Medical DevicesFDA
Beckman Coulter, Inc. recalls Discrete photometric chemistry analyzer for clinical use.
Hazard: Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module. Customers affected by this issue may observe an increase in reagent carousel motion errors or QSMC errors that occur while unloading or loading reagent packs during system initialization and sample processing, which causes a non-operational system status and cancels tests; and patient results may be delayed if these errors cancel test processing.
August 21, 2024Medical DevicesFDA
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Hazard: The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.
August 21, 2024Medical DevicesFDA
Defibtech, LLC recalls RMU-2000 Automated Chest Compression Device
Hazard: Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.
August 21, 2024Medical DevicesFDA
ICU Medical Inc recalls Plum 360/A+ spare batteries. Item Number: SUB0000864.
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
August 21, 2024Medical DevicesFDA
ICU Medical Inc recalls Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Number
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
August 21, 2024Medical DevicesFDA
ICU Medical Inc recalls Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
August 21, 2024Medical DevicesFDA
Palodex Group Oy recalls Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray imag
Hazard: It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%).
August 14, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou
Hazard: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
August 14, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou
Hazard: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
August 14, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/ou
Hazard: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
August 14, 2024Medical DevicesFDA
Steris Corporation recalls Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated
Hazard: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
August 14, 2024Medical DevicesFDA
Steris Corporation recalls Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus
Hazard: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
August 14, 2024Medical DevicesFDA
Steris Corporation recalls Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus
Hazard: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
August 14, 2024Medical DevicesFDA
Steris Corporation recalls Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A
Hazard: IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
August 14, 2024Medical DevicesFDA
LINEAGE BIOMEDICAL, INC recalls NavaClick Syringe and Needle, Model Number LIN02
Hazard: Incorrect GTIN number on carton.
August 14, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for I
Hazard: Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
August 14, 2024Medical DevicesFDA
Luminex Corporation recalls Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Hazard: Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
August 14, 2024Medical DevicesFDA
Artivion, Inc recalls (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue
Hazard: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
August 14, 2024Medical DevicesFDA
Artivion, Inc recalls CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with Syner
Hazard: Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
August 14, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Hazard: Improperly performed testing prior to release
August 14, 2024Medical DevicesFDA
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Hazard: An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
August 14, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model Num
Hazard: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
August 14, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Mode
Hazard: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
August 14, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model
Hazard: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
August 14, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Mod
Hazard: The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
August 14, 2024Medical DevicesFDA
American Contract Systems, Inc. recalls American Contract Systems Spine Pack convenience kit
Hazard: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber