All Recalls

95,075 total recalls in our database

🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).

Edwards Lifesciences

🏥 Medical Devices Class I - Dangerous

Pre-procedural issues related to software defects

Oct 2, 2017 Diagnostic Equipment Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).

Jul 21, 2017 Other Medical Devices View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.

Jul 5, 2017 Infusion Pumps Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →

Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).

Dec 27, 2017 Diagnostic Equipment Nationwide View Details →
🏥 Medical Devices Class I - Dangerous

During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

Aug 7, 2017 Implants & Prosthetics Nationwide View Details →