32 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
FDA Recall
Open, Classified
·Noah Medical Corporation·Product code EOQ·September 12, 2025
COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.
FDA Recall
Open, Classified
·Cook Incorporated·Product code FOZ·March 5, 2026
Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)
FDA Recall
Open, Classified
·Noah Medical·Product code EOQ·October 25, 2024
Incisive CT, software version 5.0
FDA Recall
Open, Classified
·Philips Healthcare·Product code JAK·August 2, 2023
Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure convenience tray
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OJH·March 1, 2024
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
FDA Recall
Open, Classified
·Noah Medical·Product code EOQ·March 9, 2024
Galaxy System (GAL-001)
FDA Recall
Open, Classified
·Noah Medical·Product code EOQ·October 25, 2024
Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.
FDA Recall
Open, Classified
·Noah Medical·Product code EOQ·October 28, 2024
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
FDA Recall
Open, Classified
·Inari Medical Oak Canyon·Product code QEW·July 19, 2024
Artix MT Thrombectomy Device, REF: 32-102
FDA Recall
Open, Classified
·Inari Medical Oak Canyon·Product code QEW·April 8, 2025
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
FDA Recall
Open, Classified
·Product code CAH·April 29, 2021
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
FDA Recall
Open, Classified
·Product code CAH·October 10, 2025
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAH·June 16, 2025
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
FDA Recall
Open, Classified
·Kung Shin Plastics Co. Ltd. 65-2 Erh Chia Road Ying Kuo Town Taipei Hsien Taiwan·Product code CAH·January 9, 2025
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
FDA Recall
Open, Classified
·Product code CAH·April 29, 2021
Drager SafeStar 55, Catalog No. MP01790
FDA Recall
Open, Classified
·Draeger Medical, Inc.·Product code CAH·May 16, 2022
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
FDA Recall
Open, Classified
·Draeger, Inc.·Product code CAH·June 16, 2025
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code CAH·August 29, 2022