136 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FRN·July 8, 2025
Product: STA Liatest D-Di; REF: 00515;
FDA Recall
Open, Classified
·Diagnostica Stago, Inc.·Product code DAP·September 12, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OHM·June 12, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·June 12, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code LRS·June 12, 2025
BD BBL TB Stain Kit K, Catalog (REF): 212522
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JTS·February 12, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OIB·June 12, 2025
Mito Red Light, Super Mobile
FDA Recall
Open, Classified
·MITO RED LIGHT INC·Product code ILY·February 12, 2025
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented, SmartSite Y-site 2426-0500, Back Check Valve, 3 SmartSite Y-sites 2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500, 2 SmartSite Y-Sites 2232-0007, 0.2 Micron Filter 11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites 10012144, 3 SmartSite Y-Sites, Check Valve 10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code FPA·September 11, 2025
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A
FDA Recall
Open, Classified
·Product code GBX·November 7, 2025
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
FDA Recall
Open, Classified
·Remel, Inc·Product code LRG·February 12, 2025
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A
FDA Recall
Open, Classified
·Product code GBX·November 7, 2025
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A
FDA Recall
Open, Classified
·Product code GBX·November 7, 2025
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A
FDA Recall
Open, Classified
·Product code GBX·November 7, 2025
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices.
FDA Recall
Open, Classified
·Product code GBX·November 7, 2025
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A
FDA Recall
Open, Classified
·Product code GBX·November 7, 2025
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
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code GWM·December 12, 2025
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
FDA Recall
Open, Classified
·NIPRO Technical Services, Inc.·Product code FKH·December 12, 2025
Cardiac Workstation 5000; Model Number: 860439;
FDA Recall
Open, Classified
·Philips North America·Product code DPS·September 12, 2025