DrugJan 2, 2019
Amerigen Pharmaceuticals Temozolomide Capsules, 20 mg recall — FDA D-0344-2019
Failed Dissolution Specifications
Class IIIFDA: TerminatedAmerigen Pharmaceuticals Inc.
Latest records
Latest recalls — page 1300
The newest recall records with useful source details are listed here.
DrugJan 2, 2019
Amerigen Pharmaceuticals Temozolomide Capsules, 180 mg recall — FDA D-0345-2019
Failed Dissolution Specifications
Class IIIFDA: TerminatedAmerigen Pharmaceuticals Inc.
DrugJan 2, 2019
Advanced Pharma Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable recall — FDA D-0347-2019
Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Class IFDA: TerminatedAdvanced Pharma Inc.
Medical DeviceDec 26, 2018
Cardinal Health 200 Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile recall — FDA Z-0636-2019
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceDec 26, 2018
Cardinal Health 200 Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile recall — FDA Z-0632-2019
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceDec 26, 2018
Deerfield Imaging IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) recall — FDA Z-0647-2019
Table may drift in the roll position while in use
Class IIFDA: TerminatedDeerfield Imaging, Inc.
Medical DeviceDec 26, 2018
Ortho-Clinical Diagnostics VITROS 5600 Integrated System, Version 3.3.1 & below For use in recall — FDA Z-0650-2019
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceDec 26, 2018
Konica Minolta Healthcare, Americas Bucky Stand SU-4000 Input 2017.11.17 recall — FDA Z-0659-2019
Unintentional U-Arm movement
Class IIFDA: TerminatedKonica Minolta Healthcare, Americas, Inc.
Medical DeviceDec 26, 2018
Bausch & Lomb Surgical enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated recall — FDA Z-0628-2019
Cosmetic imperfections on the surface of some lenses.
Class IIFDA: TerminatedBausch & Lomb Surgical, Inc.
Medical DeviceDec 26, 2018
Cardinal Health 200 Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile recall — FDA Z-0634-2019
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceDec 26, 2018
Diagnostica Stago Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are recall — FDA Z-0610-2019
There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
Class IIFDA: TerminatedDiagnostica Stago, Inc.
Medical DeviceDec 26, 2018
Deerfield Imaging IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 recall — FDA Z-0646-2019
Table may drift in the roll position while in use
Class IIFDA: TerminatedDeerfield Imaging, Inc.
Medical DeviceDec 26, 2018
Mazor Robotics Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative recall — FDA Z-0609-2019
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Class IIFDA: TerminatedMazor Robotics Ltd
Medical DeviceDec 26, 2018
Ortho-Clinical Diagnostics VITROS 4600 Chemistry System, Version 3.3.1 & below For use in recall — FDA Z-0653-2019
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceDec 26, 2018
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium recall — FDA Z-0615-2019
Inaccurate potassium results may be generated. When testing with control fluid and/or patient samples with low or reference range potassium concentration, elevated potassium results may be…
Class IIFDA: TerminatedAbbott Point Of Care Inc.
Medical DeviceDec 26, 2018
Cardinal Health 200 Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile recall — FDA Z-0635-2019
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceDec 26, 2018
Zimmer GmbH Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number recall — FDA Z-0644-2019
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
Class IIFDA: TerminatedZimmer GmbH
Medical DeviceDec 26, 2018
Advanced Instruments GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter recall — FDA Z-0640-2019
RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.
Class IIFDA: TerminatedAdvanced Instruments, LLC
Medical DeviceDec 26, 2018
Tosoh Bioscience AIA-360 Analyzer is capable of performing two methods of immunoassay: an recall — FDA Z-0613-2019
The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the table home sensor from detecting the table home position. If the malfunction with the table…
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceDec 26, 2018
Zimmer Biomet NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E recall — FDA Z-0630-2019
Screw is missing from the package
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceDec 26, 2018
Siemens Healthcare Diagnostics Dimension Vista 1500, Model No. 10444801 an in vitro recall — FDA Z-0617-2019
Siemens Healthcare Diagnostics has identified an issue with Dimension Vista software v.3.7 and v.3.8.1 that may result in aliquot well contamination. If a test is cancelled by the operator…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceDec 26, 2018
COVIDIEN Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult recall — FDA Z-0497-2019
Software Update: External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation
Class IFDA: TerminatedCOVIDIEN LLC
Medical DeviceDec 26, 2018
Deerfield Imaging IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) recall — FDA Z-0648-2019
Table may drift in the roll position while in use
Class IIFDA: TerminatedDeerfield Imaging, Inc.
Medical DeviceDec 26, 2018
bioMerieux VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these recall — FDA Z-0618-2019
False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.
Class IIFDA: TerminatedbioMerieux, Inc.
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