Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
GETINGE US SALES
🏥 Medical Devices Class I - Dangerous
Sterile barrier system may be compromised
All Recalls
95,038 total recalls in our database
Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
Medtronic Navigation
🏥 Medical Devices Class I - Dangerous
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
Ligamax 5 mm Endoscopic Multiple Clip Applier
Ethicon Endo-Surgery
🏥 Medical Devices Class I - Dangerous
A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
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.
🏥 Medical Devices Class I - Dangerous
Failed to meet USP minimum average value for knot pull (tensile) strength.
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.
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 Operator s 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.
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.
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.
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.
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.
🏥 Medical Devices Class I - Dangerous
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
🏥 Medical Devices Class I - Dangerous
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
🏥 Medical Devices Class I - Dangerous
It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
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.
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Young Dental Manufacturing Co
🏥 Medical Devices Class I - Dangerous
Product shelf life may be shorter than that indicated on the label.
Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
Roche Diagnostics Operations
🏥 Medical Devices Class I - Dangerous
Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).
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.
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.
🏥 Medical Devices Class I - Dangerous
This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.