Siemens Healthcare Diagnostics Inc - epoc Host 2 - Class 2 Recall
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X)...
Source: Medical Device Recalls - March 4, 2023 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics Inc - epoc NXS Host - Class 2 Recall
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583 (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 4, 2023 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE 2000/IMMULITE 2000 XPi 3gAllergy Specific lgE - Class 2 Recall
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2022 Category: Medical Devices Source Type: alerts

Siemens Healthcare Diagnostics, Inc. - IMMULITE 2000/IMMULITE 2000 XPi 3gAllergy Specific lgE - Class 2 Recall
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2022 Category: Medical Devices Source Type: alerts

IXIARO (japanese encephalitis vaccine, inactivated, adsorbed) injection, suspension [Valneva Scotland Ltd.]
Updated Date: Thu, 08 Dec 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 8, 2022 Category: Drugs & Pharmacology Source Type: alerts

IXIARO (japanese encephalitis vaccine, inactivated, adsorbed) injection, suspension [Vetter Pharma Fertigung GmbH & Co. KG]
Updated Date: Wed, 07 Dec 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 7, 2022 Category: Drugs & Pharmacology Source Type: alerts

Philips Respironics, Inc. - Omniab Advanced Intl (Flow Gen); Omnilab Advanced , JAPAN (Flow Gen) - Class 1 Recall
Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 10, 2022 Category: Medical Devices Source Type: alerts

Qiagen Sciences LLC - Class 2 Recall
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA) (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 20, 2022 Category: Medical Devices Source Type: alerts

IXIARO (japanese encephalitis vaccine, inactivated, adsorbed) injection, suspension [Vetter Pharma Fertigung GmbH & Co. KG]
Updated Date: Fri, 19 Nov 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 19, 2021 Category: Drugs & Pharmacology Source Type: alerts

BAXTER HEALTHCARE CORPORATION - Kaguya Automated Peritoneal Dialysis System (T5C8500; only registered for distribution in Japan.) - Class 2 Recall
Kaguya Automated Peritoneal Dialysis System (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 3, 2021 Category: Medical Devices Source Type: alerts

ANTI-BACTERIAL HAND JAPANESE CHERRY BLOSSOM (alcohol) gel [Bath & Body Works, Inc.]
Updated Date: Wed, 23 Jun 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 23, 2021 Category: Drugs & Pharmacology Source Type: alerts

ANTI-BACTERIAL HAND JAPANESE CHERRY BLOSSOM (alcohol) spray [Bath & Body Works, Inc.]
Updated Date: Wed, 23 Jun 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 23, 2021 Category: Drugs & Pharmacology Source Type: alerts

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