May 1, 2024Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS,
Hazard: Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
May 1, 2024Medical DevicesFDA
EBI, LLC recalls 48" Lead Wires, Replacement Part Number: 1067724-4
Hazard: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
May 1, 2024Medical DevicesFDA
EBI, LLC recalls 20" Lead Wires, Replacement Part Number: 1067724-2
Hazard: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
May 1, 2024Medical DevicesFDA
EBI, LLC recalls Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acqui
Hazard: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
May 1, 2024Medical DevicesFDA
EBI, LLC recalls Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion ac
Hazard: Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
May 1, 2024Medical DevicesFDA
XENEX Disinfection Services Inc. recalls LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the Li
Hazard: Blackout curtains are no longer recommended as a protective barrier against UV/Ozone exposure to a bystander standing in the same room, but on the other side of the curtain from where a microbial reduction device UV cycle is taking place. Bystanders in the room during the cycle may experience temporary skin reddening, feeling of sand in eyes, nausea, headache, and/or mucous membrane irritation.
May 1, 2024Medical DevicesFDA
ROUTE 92 MEDICAL INC recalls Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i
Hazard: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
May 1, 2024Medical DevicesFDA
ROUTE 92 MEDICAL INC recalls Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional de
Hazard: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
May 1, 2024Medical DevicesFDA
ROUTE 92 MEDICAL INC recalls Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices int
Hazard: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
May 1, 2024Medical DevicesFDA
ROUTE 92 MEDICAL INC recalls Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventio
Hazard: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
May 1, 2024Medical DevicesFDA
ROUTE 92 MEDICAL INC recalls Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional dev
Hazard: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
May 1, 2024Medical DevicesFDA
Zimmer, Inc. recalls NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Hazard: Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
May 1, 2024Medical DevicesFDA
Biomet, Inc. recalls Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foi
Hazard: Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
May 1, 2024Medical DevicesFDA
Alcon Research, LLC recalls Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Pa
Hazard: Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
May 1, 2024Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformi
Hazard: Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
May 1, 2024Medical DevicesFDA
Parker Laboratories, Inc. recalls Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
Hazard: Product demonstrates low viscosity.
May 1, 2024Medical DevicesFDA
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Hazard: There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
May 1, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls Alinity m System, Part Number: 08N53-002
Hazard: The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.
May 1, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version V
Hazard: On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
May 1, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
Hazard: On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
May 1, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc. recalls ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF:
Hazard: On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
May 1, 2024Medical DevicesFDA
Biomerieux Inc recalls VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984;
Hazard: Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.
May 1, 2024Medical DevicesFDA
LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Hazard: There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.
April 24, 2024Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 1
Hazard: Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
April 24, 2024Medical DevicesFDA
Smith & Nephew Medical, Ltd. recalls RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it
Hazard: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
April 24, 2024Medical DevicesFDA
Smith & Nephew Medical, Ltd. recalls RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it
Hazard: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
April 24, 2024Medical DevicesFDA
Raye's Inc. recalls SW Bari Lift & Transfer, Model Number 38060000
Hazard: Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device.
April 24, 2024Medical DevicesFDA
Randox Laboratories Ltd. recalls Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426
Hazard: Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
April 24, 2024Medical DevicesFDA
Randox Laboratories Ltd. recalls Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Hazard: Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
April 24, 2024Medical DevicesFDA
ACTIM OY recalls Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of fetal membrane
Hazard: Interference testing has shown that the presence of personal lubricants in the vaginal specimen can interfere with the PROM test result by providing a false positive result.