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Showing 5461–5480 of 11714 results

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CARTO VIZIGO Sheath (Biosense Webster) – Manufacturing Mix-Up (2024)

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

FDAFeb 16, 2024Nationwide• Biosense Webster, Inc.

Rad-G Pulse Oximeter (Masimo) – Power Monitoring Risk (2024)

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

FDAFeb 15, 2024Nationwide• Masimo Corporation

Mariner RDX Head (SeaSpine) – Screw Threading Risk (2024)

Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

Moderate

FDAFeb 15, 2024Nationwide• SEASPINE ORTHOPEDICS CORPORATION

HotDog Return Electrode (Augustine) – Electrode Contact Issue (2024)

Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

FDAFeb 15, 2024AL, NV, TX• Augustine Temperature Management, LLC

QXDx BCR-ABL Kit (Bio-Rad) – Calibration Inaccuracy (2024)

Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

FDAFeb 15, 2024Nationwide• Bio-Rad Laboratories

DIVA LCD Display (Philips) – Touch Input Malfunction (2024)

If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm, there is a potential for a delay in the detection of a change in a patient condition which prompted the alarm to generate. Although unlikely, this could potentially result in a patient harm.

FDAFeb 15, 2024Nationwide• Philips North America Llc

Rad-G Pulse Oximeter (Masimo) – Power Monitoring Risk (2024)

Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.

FDAFeb 15, 2024Nationwide• Masimo Corporation

Methocarbamol Injection (Eugia) – particulate matter (2024)

Presence of Particulate Matter

FDAFeb 15, 2024Nationwide• Eugia US LLC

Covidien Signia Reload (Unknown) – Staple Line Disruption (2024)

Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.

FDAFeb 14, 2024Nationwide

Signia Curved Tip Reload (Unknown) – Staple Line Disruption (2024)

Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.

FDAFeb 14, 2024Nationwide

Cystatin C Calibrator (Randox) – Bias Concern (2024)

Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods

FDAFeb 14, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

STERIS Traction Boot (Baxter) – Locking Pin Defect (2024)

Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.

FDAFeb 14, 2024Nationwide• Baxter Healthcare Corporation

Fluticasone Nasal Spray (Golden State Medical) – bacterial contamination risk (2024)

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Class IIModerate

FDAFeb 14, 2024Nationwide• Golden State Medical Supply Inc.

GeoMed Tracecarts (DeRoyal) – Component Recall Risk (2024)

DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

FDAFeb 13, 2024FL• DeRoyal Industries Inc

TMini Knee Instrument (Think Surgical) – Array Guide Issue (2024)

There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.

FDAFeb 12, 2024Nationwide• Think Surgical, Inc.

POLARSHEATH Steerable Sheath (Boston Scientific) – Manufacturing Defect (2024)

Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).

FDAFeb 12, 2024Nationwide• Boston Scientific Corporation

QuickFlash Artery Catheterization (Arrow) – Component Defect (2024)

Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.

FDAFeb 12, 2024Nationwide• ARROW INTERNATIONAL Inc.

Curaplex Intubation Kit (Sarnova) – Tube Holder Incompatibility (2024)

Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

FDAFeb 12, 2024Nationwide• Sarnova HC, Llc

Clobazam Tablets (Micro Labs) – Residual Solvent Issue (2024)

CGMP Deviations: Out of specification for residual solvents.

Class IIModerate

FDAFeb 12, 2024Nationwide• Micro Labs Limited

Brazil Seed 2-Pack (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

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