Medical DeviceSep 26, 2018
Mako Surgical Makoplasty RIO Standard System recall — FDA Z-3182-2018
Communication-connection error.
Class IIFDA: TerminatedMako Surgical Corporation
September 2018 recalls — page 3
These records include useful source details for the selected month.
Medical DeviceSep 26, 2018
Invivo Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version recall — FDA Z-3192-2018
Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate…
Class IIFDA: TerminatedInvivo Corporation
Medical DeviceSep 26, 2018
Siemens Medical Solutions USA ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model recall — FDA Z-3190-2018
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceSep 26, 2018
Degania Silicone Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product recall — FDA Z-2760-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
Degania Silicone Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP recall — FDA Z-2771-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
Degania Silicone Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number recall — FDA Z-2775-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
Mobius Imaging AIRO Mobile CT System Model # MobiCT-32 recall — FDA Z-2991-2018
The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan…
Class IIFDA: TerminatedMobius Imaging, LLC
Medical DeviceSep 26, 2018
Ortho-Clinical Diagnostics VITROS Chemistry Products CREA Slides, Product Code 680 2584 recall — FDA Z-3193-2018
The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low…
Class IIIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceSep 26, 2018
Stryker Medical Division of Stryker IsoFlex LAL Support Surface, Model Number 2860 Product recall — FDA Z-3181-2018
Certain 2860 IsoFlex LAL support surfaces were assembled with a non-conforming fire barrier.
Class IIFDA: TerminatedStryker Medical Division of Stryker Corporation
Medical DeviceSep 26, 2018
bioMerieux VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp recall — FDA Z-3179-2018
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level…
Class IIFDA: TerminatedbioMerieux, Inc.
Medical DeviceSep 26, 2018
Degania Silicone Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP recall — FDA Z-2770-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
Accuray Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to recall — FDA Z-3211-2018
the Ball Cube II phantom calibration film was not manufactured within necessary dimensions and may introduce up to 0.5 mm of positional inaccuracy to the CyberKnife System
Class IIFDA: TerminatedAccuray Inc.
Medical DeviceSep 26, 2018
Medtronic Contour Plus Link 2.4, Product recall — FDA Z-3201-2018
CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.
Class IIFDA: TerminatedMedtronic Inc.
Medical DeviceSep 26, 2018
Degania Silicone Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number recall — FDA Z-2763-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
Biocare Medical URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package recall — FDA Z-3198-2018
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
Class IIFDA: TerminatedBiocare Medical, LLC
Medical DeviceSep 26, 2018
Degania Silicone Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product recall — FDA Z-2782-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
Arrow International 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 recall — FDA Z-3199-2018
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceSep 26, 2018
Zimmer Biomet Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629 recall — FDA Z-3177-2018
The Gentle Thread PLGA Round Head, 7x20mm and the Gentle Thread PLGA Full Thread 10x30 have been commingled.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceSep 26, 2018
Degania Silicone Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product recall — FDA Z-2783-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
bioMerieux VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp recall — FDA Z-3180-2018
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level…
Class IIFDA: TerminatedbioMerieux, Inc.
Medical DeviceSep 26, 2018
Degania Silicone Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product recall — FDA Z-2761-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
ShinChang Medical Co Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2 recall — FDA Z-3202-2018
Defect consists of a small crack in the top end of the barrel near the needle.
Class IIFDA: TerminatedShinChang Medical Co., Ltd.
Medical DeviceSep 26, 2018
Degania Silicone Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB recall — FDA Z-2756-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceSep 26, 2018
Degania Silicone Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number recall — FDA Z-2772-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.