37 results
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21ms
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Sources: EU EUDAMED, US FDA
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
FDA Recall
Open, Classified
·Product code BYS·October 11, 2023
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
FDA Recall
Open, Classified
·Product code BYS·October 11, 2023
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical biopsy
FDA Recall
Open, Classified
·Sklar Instruments·Product code HCY·December 3, 2024
JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code JWH·September 27, 2023
JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code JWH·September 27, 2023
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code JWH·June 13, 2018
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
FDA Recall
Open, Classified
·Smith & Nephew, Inc.·Product code JWH·June 13, 2018
HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
FDA Recall
Open, Classified
·HeartSine Technologies Ltd
207 Airport Road West
Belfast United Kingdom·Product code MKJ·February 14, 2024
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S
FDA Recall
Open, Classified
·EMPATICA SRL Via Enrico Stendhal·Product code POS·July 13, 2023
Bard Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code BSS·December 20, 2023
Bard Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code BSS·December 20, 2023
Bard Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code BSS·December 20, 2023
Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code BSS·December 20, 2023
Bard Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
FDA Recall
Open, Classified
·C.R. Bard Inc·Product code BSS·December 20, 2023
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024
Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes. Component: N/A
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexible endoscopes.
FDA Recall
Open, Classified
·Steris Corporation·Product code FEB·June 13, 2024
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002
FDA Recall
Open, Classified
·Phadia US Inc·Product code MST·May 1, 2023
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782108 2) 781359 3) 782133
FDA Recall
Open, Classified
·Philips North America Llc·Product code LNH·September 3, 2024