All device recalls

Altruan GmbH recalls Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic strep…

Product not cleared by the FDA.

• Streptococcus Spp. All Groups Antigens
• No Marketing Application

Lutronic Corporation recalls CLARITY II Laser System

Reports of devices sparking/popping and potentially burning patients.

• Powered Laser Surgical Instrument
• Device Design

Covidien LLC recalls HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Nu…

Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

• Patient (Without Arrhythmia Detection Or Alarms) Physiological Monitor
• Under Investigation by firm

International Life Sciences recalls Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm…

Augmentation devices failed bacterial endotoxin testing.

• Reinforcement Of Tendon Orthopaedics Absorbable Surgical Mesh
• Process control

International Life Sciences recalls Artelon FlexBand Plus Ref: 41054 & 41057

Augmentation devices failed bacterial endotoxin testing.

• Reinforcement Of Tendon Orthopaedics Absorbable Surgical Mesh
• Process control

International Life Sciences recalls Artelon FlexBand Dynamic Matrix Ref: 31057

Augmentation devices failed bacterial endotoxin testing.

• Reinforcement Of Tendon Orthopaedics Absorbable Surgical Mesh
• Process control

Beckman Coulter Mishima K.K. recalls CHEMISTRY ANALYZER AU5800

A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases no…

Beckman Coulter Mishima K.K. recalls DxC 700 AU

A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases no…

Boston Scientific Corporation recalls EndoVive Safety PEG Kit

Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution.…

• Gastrointestinal Tubes With Enteral Specific Connectors
• Process control

Medartis AG recalls Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

• Bone Fixation Screw
• Labeling mix-ups

Medartis AG recalls Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

• Bone Fixation Screw
• Labeling mix-ups

Trividia Health, Inc. recalls Owner's Booklets and Instructions for Use that are used with the following blood glucos…

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code.…

• Over The Counter Blood Glucose Test System
• Software design