BEUDAMED
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    VITROS XT Chemistry Products TBIL-ALKP Slides

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code CIG·August 5, 2023

    Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CIG·July 30, 2024

    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·August 13, 2025

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·May 1, 2021

    Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL LN DRG CHG, Kit SKU DT22880; 2) ADULT CVC DRSG CHG W/ADHESIVE, Kit SKU DYNDC3283A.

    FDA Recall
    Open, Classified ·Product code OXQ·December 12, 2025

    Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·December 27, 2022

    MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·September 9, 2022

    3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code FRO·August 14, 2024

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·April 1, 2025

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CT

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPS·May 1, 2021

    Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·October 9, 2023

    Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATION PACK DYNJ62889C

    FDA Recall
    Open, Classified ·Product code OFF·April 27, 2026

    Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP1131

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP SPT·Product code OJU·June 6, 2022

    Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FPO·May 12, 2021

    Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code OFK·April 21, 2026

    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No

    FDA Recall
    Open, Classified ·Trinity Sterile, Inc.·Product code OXQ·December 13, 2024

    Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No

    FDA Recall
    Open, Classified ·Trinity Sterile, Inc.·Product code OXQ·December 13, 2024

    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025