Thoratec Corp. - HeartMate II Left Ventricular Assist System - Class 1 Recall
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate IITM Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate IITM LVAS Implant Kit, US REF 106015 3. HeartMate IITM LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II¿ LVAS Implant Kit, OUS REF 102139 2. HeartMate II¿ LVAS Implant Kit, US REF 1355 3. HeartMate II¿ LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II¿ LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II¿ LVAS Implant Kit (with Sealed Graft), US REF 1...
Source: Medical Device Recalls - March 23, 2024 Category: Medical Devices Source Type: alerts
IXIARO (japanese encephalitis vaccine, inactivated, adsorbed) injection, suspension [Vetter Pharma Fertigung GmbH & Co. KG]
Updated Date: Wed, 13 Dec 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 13, 2023 Category: Drugs & Pharmacology Source Type: alerts
IMMUNE ESSENCE TO PROLONG LIFE (immune essence capsule to prolong life) capsule [Japan Chuangyan Biopharmaceutical Co., Ltd]
Updated Date: Tue, 11 Jul 2023 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 11, 2023 Category: Drugs & Pharmacology Source Type: alerts
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
