DrugDec 28, 2016
KYPROLIS AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion recall — FDA D-0226-2017
Lack of Assurance of Sterility: Potential cracks in glass vials
Class IIFDA: TerminatedAmgen, Inc.
Latest records
Latest recalls — page 1742
The newest recall records with useful source details are listed here.
Medical DeviceDec 21, 2016
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray recall — FDA Z-0733-2017
Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse…
Class IIFDA: TerminatedCook Inc.
Medical DeviceDec 21, 2016
Siemens Medical Solutions USA SOMATOM Definition Flash System, x-ray, tomography, computed recall — FDA Z-0743-2017
Software update that provides software and firmware bug-fixes to improve system performance
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceDec 21, 2016
Ulthera Cellfina Prep Pack, Part No recall — FDA Z-0749-2017
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure…
Class IIFDA: TerminatedUlthera Inc.
Medical DeviceDec 21, 2016
Steris Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system recall — FDA Z-0746-2017
The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose.
Class IIFDA: TerminatedSteris Corporation
Medical DeviceDec 21, 2016
Stryker Medical Division of Stryker Performance-LOAD Ambulance Cot Fastener Stretcher recall — FDA Z-0739-2017
Stryker Medical initiated a voluntary recall of Stryker Performance-LOAD Cot Fasteners due to complaints that fastening system may not have been securely fastened or had an inability to…
Class IIFDA: TerminatedStryker Medical Division of Stryker Corporation
Medical DeviceDec 21, 2016
Siemens Medical Solutions USA SOMATOM Definition AS System, x-ray, tomography, computed recall — FDA Z-0742-2017
Software update that provides software and firmware bug-fixes to improve system performance
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceDec 21, 2016
Accuray CyberKnife Robotic Radiosurgery System using software version 10.6 recall — FDA Z-0734-2017
Accuray has become aware of a potential safety issue involving unexpected treatment robot motion when removing an accessory. This issue is limited to certain CyberKnife Systems with…
Class IIFDA: TerminatedAccuray Inc.
Medical DeviceDec 21, 2016
Ecolab recall — FDA Z-0753-2017
The reason for the recall is that the inner carton box of the Rolled Probe Cover PC0907NB has the incorrect expiration date (2015-10-01) on the label while the individual pouch labels and…
Class IIIFDA: TerminatedEcolab Inc.
Medical DeviceDec 21, 2016
ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar recall — FDA Z-0748-2017
Mislabeling of the "expiration date". The expiration date on the outer box and the individual pouches do not match. The expiration date on the box is correct with a date of 2018-02.
Class IIFDA: TerminatedEllman International, Inc.
Medical DeviceDec 21, 2016
Merge Cardio software recall — FDA Z-0730-2017
Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceDec 21, 2016
Teleflex Medical WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex recall — FDA Z-0764-2017
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
Class IIFDA: TerminatedTeleflex Medical
Medical DeviceDec 21, 2016
Stryker Sustainability Solutions Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP recall — FDA Z-0765-2017
An increase in reports indicating that the reprocessed H12LP Trocar adjustable plug may break in the packaging or during use.
Class IIFDA: TerminatedStryker Sustainability Solutions
Medical DeviceDec 21, 2016
CYPRESS MEDICAL PRODUCTS McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116 recall — FDA Z-0741-2017
A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
Class IIFDA: TerminatedCYPRESS MEDICAL PRODUCTS
Medical DeviceDec 21, 2016
Pentax of Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is recall — FDA Z-0757-2017
The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the…
Class IIFDA: TerminatedPentax of America Inc.
Medical DeviceDec 21, 2016
Integra York PA Metzenbaum Scissors 7 , Curved, Sterile The Metzenbaum Scissors 7 , Curved recall — FDA Z-0752-2017
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
Class IIFDA: TerminatedIntegra York PA, Inc.
Medical DeviceDec 21, 2016
INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can recall — FDA Z-0760-2017
Device can fail during operation.
Class IIFDA: TerminatedInovo, Inc.
Medical DeviceDec 21, 2016
C.R. Bard BARDIA 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD Syringe is recall — FDA Z-0738-2017
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
Class IIFDA: TerminatedC.R. Bard, Inc.
Medical DeviceDec 21, 2016
Siemens Medical Solutions USA SOMATOM Definition Edge System, x-ray, tomography, computed recall — FDA Z-0744-2017
Software update that provides software and firmware bug-fixes to improve system performance
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceDec 21, 2016
Merge Cardio software recall — FDA Z-0729-2017
If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to…
Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceDec 21, 2016
PerkinElmer Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized recall — FDA Z-0747-2017
Filter Tips molded incorrectly and may not seal to the Varispan tip adaptor properly causing inaccurate aspiration and dispensing
Class IIFDA: TerminatedPerkinElmer, Inc.
Medical DeviceDec 21, 2016
Physio-Control The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical recall — FDA Z-0761-2017
Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be…
Class IIFDA: TerminatedPhysio-Control, Inc.
Medical DeviceDec 21, 2016
Integra York PA Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile recall — FDA Z-0751-2017
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
Class IIFDA: TerminatedIntegra York PA, Inc.
Medical DeviceDec 21, 2016
Oculus Innovative Sciences Ceramax Skin Barrier Cream: NET WT 0.1 OZ recall — FDA Z-0763-2017
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
Class IIFDA: TerminatedOculus Innovative Sciences, Inc.
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Recent recall archives
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