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Sources: EU EUDAMED, US FDA
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Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.
FDA Enforcement
Class II
·Terminated·S.A.E. AFIKIM·November 6, 2013
TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two synthetic absorbable sutures, each attached to a synthetic absorbable anchor. The deployment of the anchors and sutures is achieved by utilizing a mechanism within the Obturator. The Cannula is 115 mm long and is compatible for use with laparoscopic devices of 5 - 12 mm outer diameter.
FDA Enforcement
Class II
·Terminated·Gordian Surgical·November 11, 2020
Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
FDA Enforcement
Class I
·Ongoing·EITAN MEDICAL LTD·October 25, 2023
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
FDA Enforcement
Class II
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·July 16, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870
FDA Enforcement
Class II
·Terminated·Biosense Webster (israel), Ltd.·September 2, 2020
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, QMVAI; Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVAIH
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.
FDA Enforcement
Class II
·Terminated·Mazor Robotics Ltd·December 26, 2018
Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology Length 7 (2.0 m), XS04620COV; CapnoLine Adult-Pediatric Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), XS04624COV
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM FilterLine H Set Long Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 007738; MICROSTREAM VitaLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 010807.
FDA Enforcement
Class II
·Ongoing·Oridion Medical 1987 Ltd.·March 26, 2025
Capnostream20 M W/PRINTER CYVITAL, CS08796
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (US) M TO MASIMO, Part Number CS08750
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 (INTL) N REFURBISHED, CS78652
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 M ADULT ICU (CPM), CS08654RA
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
Capnostream20 N W/PRINTER CYVITAL, CS08798
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
FDA Enforcement
Class II
·Ongoing·CORNEAT VISION, LTD.·October 15, 2025
Capnostream20 (INTL) N W/PRINTER REFURBISHED, CS78658
FDA Enforcement
Class II
·Terminated·Oridion Medical 1987 Ltd.·October 10, 2018