18 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
FDA Recall
Open, Classified
·WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany·Product code HIG·July 17, 2023
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
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
Palmero Healthcare, LLC DisCide Ultra Surface Disinfectant Cleaner Quaternary Based Manual Pour Liquid 1 gal. Jug Herbal Scent NonSterile Model Number: 3565G
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code LRJ·May 25, 2022
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
Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
FDA Recall
Open, Classified
·Product code GAL·March 1, 2023
Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
FDA Recall
Open, Classified
·Product code GAL·March 1, 2023
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.
FDA Recall
Open, Classified
·CP Medical Inc·Product code GAL·February 4, 2019
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45CM P12 X36 (SG-5637), CHROMIC GUT 5-0 45CM P-13 X12 (SG-5687G), CHROMIC GUT 5-0 75CM CV23 (UG-202), CHROMIC GUT 4-0 75CM CV23 X36 (UG-203)
FDA Recall
Open, Classified
·Product code GAL·March 1, 2023
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA Recall
Open, Classified
·CORENTEC CO., LTD 12 Yeongsanhong1-Gil; Seobuk Cheonan Korea (the Republic of)·Product code JWH·March 29, 2024
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
FDA Recall
Open, Classified
·CORENTEC CO., LTD 12 Yeongsanhong1-Gil; Seobuk Cheonan Korea (the Republic of)·Product code JWH·March 29, 2024
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Recall
Open, Classified
·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·March 31, 2023
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Recall
Open, Classified
·SD Biosensor, Inc. 1556 Beon-Gil, Yeongtong C4th & 5th Floor Digital Empire·Product code QKP·January 31, 2022
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025