11 results · 12ms · Sources: EU EUDAMED, US FDA

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Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

FDA Recall
Open, Classified ·Getinge Disinfection Ab Ljungadalsgatan·Product code MEC·August 29, 2025

B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

B125M Patient Monitor, REF 6160000-005-XXXXXXX

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

B105M Patient Monitor, REF 6160000-003

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

B125M Patient Monitor, REF 6160000-004-XXXXXX

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

B125P Patient Monitor (with E-module slot option), REF 6160000-002

FDA Recall
Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

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

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

MICRO-X Rover Mobile X-ray System, # MXU-RV35

FDA Recall
Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 22, 2024

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) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.

FDA Recall
Open, Classified ·Neilmed Pharmaceuticals Inc·Product code KCJ·December 28, 2024

BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

FDA Recall
Open, Classified ·Becton Dickinson Infusion Therapy Systems Inc.·Product code FOZ·September 8, 2021