22 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
FDA Recall
Open, Classified
·Smith & Nephew Inc.·Product code GDW·August 12, 2024
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
FDA Recall
Open, Classified
·Smith & Nephew Inc.·Product code GDW·August 12, 2024
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
FDA Recall
Open, Classified
·Elekta, Inc.·Product code IYE·May 5, 2023
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 23, 2024
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 23, 2024
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 23, 2024
UA KIT, SKU DYKM1690A; Component No. 503581
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 23, 2024
Lab Kit, SKU DYLAB1018; Component No. 503581
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 23, 2024
URINE KIT, SKU DYKM1845; Component No. 503581
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 23, 2024
URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 23, 2024
URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·October 23, 2024
Shimadzu, Trinias, Digital Angiography System
FDA Recall
Open, Classified
·SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku·Product code OWB·January 29, 2024
Inspire Model 3028, IV Implantable Pulse Generator
FDA Recall
Open, Classified
·Inspire Medical Systems Inc.·Product code MNQ·May 16, 2024
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD CULTURE KIT, Medline Kit SKU DYNDH1520; 2. BLOOD DRAW KIT, Medline Kit SKU EBSI1317.
FDA Recall
Open, Classified
·Product code OIB·March 16, 2026
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
FDA Recall
Open, Classified
·Product code OJU·March 16, 2026
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal Central/Art Line Insertion Kit, Medline Kit SKU ART155A
FDA Recall
Open, Classified
·Product code CBT·March 16, 2026
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL PURPOSE TRAY, Medline Kit SKU 75670
FDA Recall
Open, Classified
·Product code LRP·March 16, 2026
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEX·January 29, 2024
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEX·January 29, 2024
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B; 4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B; 5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A; 6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A; 7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810; 8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100; 9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340; 10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660; 11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.
FDA Recall
Open, Classified
·Product code OXQ·March 16, 2026