Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-06-13FDA-DeviceOrthofix, IncClass IILocking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0MM X 18MM (002-E-20018); g) D 2.0MM X 20MM (002-E-20020); h) D 2.0MM X 22MM (002-E-20022); i) D 2.0MM X 24MM (002-E-20024); j) D 2.0MM X 26MM (002-E-20026); k) D 2.0MM X 28MM (002-E-20028); l) D 2.0MM X 30MM
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IINon-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM (002-D-20018); g) D 2.0MM X 20MM (002-D-20020); h) D 2.0MM X 22MM (002-D-20022); i) D 2.0MM X 24MM (002-D-20024); j) D 2.0MM X 26MM (002-D-20026); k) D 2.0MM X 28MM (002-D-20028); l) D 2.0MM X 30MM (002-D-2003
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIRival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIRival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceOrthofix, IncClass IIRival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
- 2018-06-13FDA-DeviceInvivo CorporationClass IIXper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, Sp02 (Pulse Oximetry), End Tidal C02 (carbon dioxide) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output cur
While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window.
- 2018-06-13FDA-DeviceSmiths Medical ASD Inc.Class IIBivona¿ Tracheostomy Tube Tracheostomy Tubes
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
- 2018-06-13FDA-DeviceBaxter Healthcare CorporationClass IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal
The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.
- 2018-06-13FDA-DeviceBaxter Healthcare CorporationClass IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous,
The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.
- 2018-06-13FDA-DeviceCareFusion 303, Inc.Class IIAlaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.
Reports of incorrect priming volume due to manufacturing with incorrect tubing.
- 2018-06-13FDA-DeviceFresenius Medical Care Renal Therapies Group, LLCClass IINaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Pur
The bottles are mislabeled with an incorrect part number.
- 2018-06-13FDA-DeviceIon Beam Applications S.A.Class II12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.
IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.
- 2018-06-13FDA-DeviceMEDTECH SASClass IIROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It
Replacement of units lacking an updated device approval.
- 2018-06-13FDA-DeviceMicroAire Surgical Instruments, LLCClass IIMicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
- 2018-06-13FDA-DeviceDatascope CorporationClass IIIMaquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
- 2018-06-13FDA-DeviceDatascope CorporationClass IIIMaquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
- 2018-06-13FDA-DeviceDatascope CorporationClass IIIMaquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
- 2018-06-13FDA-DeviceNordicNeuroLab ASClass IIfMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.
Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.
- 2018-06-13FDA-DeviceGE HealthcareClass IICentricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be in
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
- 2018-06-13FDA-DeviceGE HealthcareClass IICentricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images m
Potential that one or more image series may be missing from an exam without a user warning displayed in the Viewer.
- 2018-06-13FDA-DeviceVGI Medical, LLCClass IIVGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit
IFU contained an automated cleaning process for the VerteLP Instrument Tray that was not validated
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK Fer; Part Number: 025253 Assay, Anemia
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
- 2018-06-13FDA-DeviceTosoh Bioscience IncClass IIST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
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