Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
- 2018-05-16FDA-DeviceDeerfield Imaging, Inc.Class IIIMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.
The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.
- 2018-05-16FDA-DeviceMako Surgical CorporationClass IIRESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Incorrect product and/or label. Sizing is labeled incorrectly.
- 2018-05-16FDA-DeviceBeckman Coulter Inc.Class IIBECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well a
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.
- 2018-05-16FDA-DeviceMaquet Cardiopulmonary AgClass IICARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and required for inter-hospital patient transport in aircraft and road vehicles (mobile intensive care units and ambulances). Inter-hospital patient transport is transport of the patient between clinics, where the clinical environment is left (e.g., transport in vehicles such as ambulances or aircraft). The
There is a possibility for the clamps of the gas bottle holder to crack or break when exposed to strong vibrations.
- 2018-05-16FDA-DeviceMedtronic Sofamor Danek USA IncClass IIMedtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
- 2018-05-16FDA-DeviceVygon U.S.A.Class IIPICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
- 2018-05-16FDA-DeviceVygon U.S.A.Class IIPICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
- 2018-05-16FDA-DeviceVygon U.S.A.Class IIMaximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
- 2018-05-16FDA-DeviceVygon U.S.A.Class IIPICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
- 2018-05-16FDA-DeviceVygon U.S.A.Class IIMaximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
- 2018-05-16FDA-DeviceVygon U.S.A.Class IIMaximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
- 2018-05-16FDA-DeviceVygon U.S.A.Class IINeonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
- 2018-05-16FDA-DeviceVygon U.S.A.Class IIPICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
Potential friction holes may affect the sterility of the product.
- 2018-05-16FDA-DeviceMichigan Instruments, Inc.Class IIIThumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
A performance issue with the chest depth needle valve (CDNV) may arise where turning the knob will not deliver any compression depth to the piston during the first 5 revolutions of the knob.The last ¿ to ¿ revolution of the knob could deliver a full 8cm of compression.
- 2018-05-16FDA-DeviceRandox Laboratories Ltd.Class IILipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional Use for the quantitative in vitro determination of Lipase in human serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Randox has now released further steps to avoid contamination of the Lipase Assay on Rx instruments.
- 2018-05-16FDA-DeviceIntegra LifeSciences Corp.Class IIManuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to wound healing Ideal for minor scalds and burns, minor cuts, lacerations and minor abrasions
Incorrect gel part number listed in a master manufacturing record
- 2018-05-16FDA-DeviceAbbott Gmbh & Co. KGClass IIARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
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