December 20, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls STERILE PVP SLN KIT, REF DYNDM1097
Hazard: The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
December 20, 2023Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls STERILE PVP SOLUTION, REF DYNDA1907
Hazard: The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
December 20, 2023Medical DevicesFDA
Limacorporate S.p.A recalls PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Hazard: Due to incorrect product labeling
December 20, 2023Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Hazard: Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
December 20, 2023Medical DevicesFDA
Medtronic Inc. recalls Medtronic SynchroMed, Model A10
Hazard: The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
December 20, 2023Medical DevicesFDA
Meridian Bioscience Inc recalls Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of s
Hazard: Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
December 20, 2023Medical DevicesFDA
Meridian Bioscience Inc recalls Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimen
Hazard: Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
December 20, 2023Medical DevicesFDA
Meridian Bioscience Inc recalls Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing inte
Hazard: Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
December 20, 2023Medical DevicesFDA
Riverpoint Medical, LLC recalls Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S
Hazard: Use of a 1.4 drill in hard bone conditions caused increased insertion forces leading to subsequent failures of the inserter, when the inserters bend, it may also move off the drill hole location leading to damage of the suture construct during insertion. Suture damage may lead to suture breaks during use.
December 20, 2023Medical DevicesFDA
Bebig Isotopentechnik Gmbh recalls SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
Hazard: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
December 20, 2023Medical DevicesFDA
BioReference Health, LLC recalls The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total P
Hazard: Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.
December 20, 2023Medical DevicesFDA
Spectranetics Corporation recalls Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy C
Hazard: Incorrect product labeling. Exterior product box label does not match internal pouch label.
December 20, 2023Medical DevicesFDA
Philips North America Llc recalls Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst
Hazard: Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.
December 13, 2023Medical DevicesFDA
Ortho-Clinical Diagnostics, INc. recalls VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitat
Hazard: Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which may contain consecutive slides that may not function as intended. These affected slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased total carbon dioxide (CO2) results leading to either overdiagnosis of acidosis or missing alkalosis, both which may prompt unnecessary therapies such as IV fluids and/or bicarbonate or overdiagnosis of alkalosis which may also result in unnecessary use of IV fluids and electrolyte replacement or failure to detect acidosis and necessary treatment.
December 13, 2023Medical DevicesFDA
Encore Medical, LP recalls DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO
Hazard: Due to incorrect product/device within packaging.
December 13, 2023Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls Stay Safe Cap
Hazard: Updating the labeling to include additional warnings and contraindications for potential side effects.
December 13, 2023Medical DevicesFDA
Liberty Medical Solutions, LLC recalls Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Hazard: The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
December 13, 2023Medical DevicesFDA
CooperSurgical, Inc. recalls CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hys
Hazard: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
December 13, 2023Medical DevicesFDA
CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hystero
Hazard: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
December 13, 2023Medical DevicesFDA
CooperSurgical, Inc. recalls Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysteroson
Hazard: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
December 13, 2023Medical DevicesFDA
Randox Laboratories Ltd. recalls RANDOX Total Bilirubin.
Hazard: Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
December 13, 2023Medical DevicesFDA
Luminex Corporation recalls Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a c
Hazard: Potentially defective utility trays in the reagent kits.
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the br
Hazard: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:
Hazard: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number
Hazard: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number
Hazard: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:
Hazard: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number
Hazard: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe
Hazard: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
December 13, 2023Medical DevicesFDA
Integra LifeSciences Corp. recalls Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe
Hazard: Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device