16 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pack Number DYNJ46518G ; 4) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007A ; 5) EH EMERGENCY TRACH TRAY , Pack Number DYNJ50007B ; 6) ENT TRACHEOTOMY , Pack Number DYNJ55523C ; 7) DR NIELSON THORACOSCOPY , Pack Number DYNJ61471A ; 8) TRACH PACK, Pack Number DYNJ64583; 9) TRACHEOSTOMY, Pack Number DYNJ902123G; 10) TRACHEOSTOMY, Pack Number DYNJ902123I; 11) TRACHEOSTOMY, Pack Number DYNJ902123J; 12) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525 ; 13) (55) KIT STC TRACHEOSTOMY , Pack Number DYNJ909525H; 14) BEDSIDE TRACHEOTOMY , Pack Number DYNJ909743
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code NXA·April 8, 2024
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B ; 3) SALEM CATH LAB-LF , Pack Number DYNJ26938J ; 4) EH PEDIATRIC CATH , Pack Number DYNJ49920L ; 5) ARTERIOGRAM PACK, Pack Number DYNJ53018; 6) CATH PACK , Pack Number DYNJ57729C ; 7) PEDS CATH PACK, Pack Number DYNJ66856; 8) PEDS CATH PACK, Pack Number DYNJ66856A ; 9) STEWARD ROCKLEDGE CATH RRS, Pack Number DYNJ81061A ; 10) CATH LAB PACK , Pack Number DYNJ84617; 11) UA/UV CATHETERIZATION TRAY, Pack Number UVT1190A
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OES·April 8, 2024
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code GEH·August 18, 2025
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code GEH·August 18, 2025
Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
FDA Recall
Open, Classified
·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code GEH·March 24, 2025
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
FDA Recall
Open, Classified
·AtriCure, Inc.·Product code GEH·November 28, 2023
Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;
FDA Recall
Open, Classified
·New Medical Technologies Gmbh Wankdorffeldstrasse·Product code GEH·December 19, 2024
Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
FDA Recall
Open, Classified
·Erbe USA Inc·Product code GEH·February 12, 2026
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)
FDA Recall
Open, Classified
·Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel·Product code GEH·September 16, 2019
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
FDA Recall
Open, Classified
·AtriCure, Inc.·Product code GEH·November 28, 2023
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code GEH·March 24, 2025
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code GEH·March 24, 2025
IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code GEH·March 24, 2025