155 results
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17ms
·
Sources: EU EUDAMED, US FDA
Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/T - ARD567234113C, 6001K SAL/T - ARD567226113C, 6101 ACS/SU - ARD567235001C, 6301 SAL/T - ARD567423111C, 6401 ACS/DF - ARD567235211C, 6401 ACS/DF - ARD567235231C, 6401 ACS/DF - ARD567235241C, 6401 SAL/DF - ARD567227211C, 6401 SAL/DF - ARD567227241C, 6401K ACS/D - ARD567235243C, 6401K SAL/SF - ARD567227113C, 6411 SAL/DF - ARD567228009C, 6441 ACS/DF - ARD567236241C, 8401 ACS/DF - ARD567231225C, 8401 ACS/DF - ARD567231241C, 8401K ACS/D - ARD567231243C, 8431 ACS/DF - ARD567431221C, 8431 ACS/DF - ARD567431241C, 8441 ACS/DF - ARD567232241C, PRISMALIX - ARD567761211C
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FSY·November 8, 2023
Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD567220111C, 4001K S/DF - ARD567211213C, 4003 - ARD567215111C, 4401 S/DF - ARD567212211C, 4401 SAD/DF - ARD567223211C, 4401 SAD/DF - ARD567223241C, 4401 SAD/SF - ARD567223111C, 4441 SAD/DF - ARD567225241C, 6001K ACS/T - ARD567234113C, 6001K SAL/T - ARD567226113C, 6101 ACS/SU - ARD567235001C, 6301 SAL/T - ARD567423111C, 6401 ACS/DF - ARD567235211C, 6401 ACS/DF - ARD567235231C, 6401 ACS/DF - ARD567235241C, 6401 SAL/DF - ARD567227211C, 6401 SAL/DF - ARD567227241C, 6401K ACS/D - ARD567235243C, 6401K SAL/SF - ARD567227113C, 6411 SAL/DF - ARD567228009C, 6441 ACS/DF - ARD567236241C, 8401 ACS/DF - ARD567231225C, 8401 ACS/DF - ARD567231241C, 8401K ACS/D - ARD567231243C, 8431 ACS/DF - ARD567431221C, 8431 ACS/DF - ARD567431241C, 8441 ACS/DF - ARD567232241C, PRISMALIX - ARD567761211C
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FSY·November 8, 2023
ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems Siemens Material Number (SMN): 10309217
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JLX·April 5, 2023
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica CH Analyzer Siemens Material Number (SMN): 11099440
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code JLX·April 5, 2023
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
FDA Recall
Open, Classified
·Busse Hospital Disposables, Inc.·Product code NXA·November 30, 2023
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
FDA Recall
Open, Classified
·Busse Hospital Disposables, Inc.·Product code NXA·November 30, 2023
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
FDA Recall
Open, Classified
·Busse Hospital Disposables, Inc.·Product code MCY·November 30, 2023
Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A
FDA Recall
Open, Classified
·Product code FOZ·January 7, 2026
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
FDA Recall
Open, Classified
·Product code KDD·January 7, 2026
Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P
FDA Recall
Open, Classified
·Product code JOL·January 7, 2026
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
FDA Recall
Open, Classified
·Product code OFX·January 7, 2026
Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A
FDA Recall
Open, Classified
·Product code NSB·January 7, 2026
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L
FDA Recall
Open, Classified
·Product code OIB·January 7, 2026
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150C
FDA Recall
Open, Classified
·Product code OGJ·January 7, 2026
Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
FDA Recall
Open, Classified
·Product code PKD·January 7, 2026
Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A
FDA Recall
Open, Classified
·Product code FMH·January 7, 2026
Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
FDA Recall
Open, Classified
·Product code PAD·January 7, 2026
Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
FDA Recall
Open, Classified
·Product code CAI·January 7, 2026
Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
FDA Recall
Open, Classified
·Product code OFT·January 7, 2026
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
FDA Recall
Open, Classified
·Product code LRO·January 7, 2026