🔍 RecallPedia

All Recalls

95,038 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,591
Consumer Products

BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.

Leica Microsystems

🏥 Medical Devices Class I - Dangerous

BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.

Nov 18, 2019 Diagnostic Equipment Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep¿ cups are a component in the Subject Kit.

Neuronetrix Solutions, LLC

🏥 Medical Devices Class I - Dangerous

Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia

Nov 7, 2019 Infusion Pumps Nationwide View Details →

iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

Conformis

🏥 Medical Devices Class I - Dangerous

Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.

Oct 25, 2019 Implants & Prosthetics Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

The Binding Site Group

🏥 Medical Devices Class I - Dangerous

Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

Feb 19, 2019 Diagnostic Equipment Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.

Boston Scientific

🏥 Medical Devices Class I - Dangerous

During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.

Nov 18, 2019 Infusion Pumps Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →

Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.

Boston Scientific

🏥 Medical Devices Class I - Dangerous

During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.

Nov 18, 2019 Infusion Pumps Nationwide View Details →

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

Oct 21, 2019 Other Medical Devices Nationwide View Details →