Ventec Life Systems, Inc. - Ventec Life systems VOCSN MultiFunction Ventilator - Class 2 Recall
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001; (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 22, 2021 Category: Medical Devices Source Type: alerts
Ortho-Clinical Diagnostics, Inc. - VITROS Chemistry Products Calibrator Kit 4 - Class 2 Recall
VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit Product No: 7541 (UDI 8750005178) All current and new lots B. VITROS Chemistry Products Fe Slides Product No: 1924547 90 Slides (UDI 10758750000289) Product No: 1515808 300 slides (UDI 10758750009244) Product No: 6802198 (Japan) 90 Slides (UDI 10758750002276) All current, new and previous lots (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 24, 2021 Category: Medical Devices Source Type: alerts
Nihon Kohden America Inc - PSG1100 Sleep Diagnostic System. - Class 2 Recall
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2021 Category: Medical Devices Source Type: alerts
ANTI-BACTERIAL HAND JAPANESE CHERRY BLOSSOM (alcohol) gel [Bath & Body Works, Inc.]
Updated Date: Thu, 17 Dec 2020 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 17, 2020 Category: Drugs & Pharmacology Source Type: alerts
Shimadzu Medical Systems - MobileDaRt Evolution - Class 2 Recall
Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 5, 2020 Category: Medical Devices Source Type: alerts
Datascope Corporation - Class 2 Recall
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01 (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2020 Category: Medical Devices Source Type: alerts
Datascope Corporation - Class 2 Recall
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2020 Category: Medical Devices Source Type: alerts
Datascope Corporation - Class 2 Recall
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2020 Category: Medical Devices Source Type: alerts
Datascope Corporation - Class 2 Recall
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2020 Category: Medical Devices Source Type: alerts
Datascope Corporation - Class 2 Recall
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2020 Category: Medical Devices Source Type: alerts
Datascope Corporation - Class 2 Recall
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2020 Category: Medical Devices Source Type: alerts
Datascope Corporation - Class 2 Recall
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 22, 2020 Category: Medical Devices Source Type: alerts
Arrow International Inc - AutoCAT IABP Series - Class 1 Recall
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2020 Category: Medical Devices Source Type: alerts
CJ Foods Voluntarily Recalls Annie Chun ’s Japanese-Style Teriyaki Noodle Bowls Due To Undeclared Peanuts
CJ Foods, Inc., a division of CJ America, Inc., of La Palma, CA, is voluntarily recalling Annie Chun ’s Japanese-Style Teriyaki Noodle Bowls because it may contain undeclared peanuts. Use of this product may cause serious allergic reaction or illness in people who have an allergy or severe sensitivit (Source: FDA Food Safety)
Source: FDA Food Safety - February 14, 2020 Category: Food Science Authors: FDA Source Type: alerts
Haemonetics Corporation - CS Bowl Set - Class 2 Recall
JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing procedure before pumping the red cell product to either a bag for gravity reinfusion into the patient or an extracorporeal circuit. (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 30, 2020 Category: Medical Devices Source Type: alerts
