5,496 results
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16ms
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Sources: EU EUDAMED, US FDA
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable
FDA Recall
Open, Classified
·Agilent Technologies Denmark ApS 42 PRODUKTIONSVEJ Glostrup Denmark·Product code NJT·August 11, 2025
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code DCN·March 11, 2025
REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code N/A·March 16, 2021
REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code ONB·March 16, 2021
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FMG·August 1, 2022
ASM Replacement Battery, Component Number SUB0000594
FDA Recall
Open, Classified
·ICU Medical Inc·Product code FRN·March 22, 2023
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·October 22, 2024
Plum Duo Precision IV Pump, 40002-0403
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FRN·April 29, 2026
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
FDA Recall
Open, Classified
·ICU Medical Inc.·Product code FPA·August 6, 2025
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
FDA Recall
Open, Classified
·ICU Medical Inc.·Product code FPA·August 6, 2025
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code ONB·September 8, 2025
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code ONB·September 8, 2025
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code ONB·September 8, 2025
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code ONB·September 8, 2025
ASM Replacement Battery, Component Number SUB0000864
FDA Recall
Open, Classified
·ICU Medical Inc·Product code FRN·March 22, 2023
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusin Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360" Infuser, Plum 360 Infuser compatible with ICU Medical MedNet Software, Plum 360 Infuser compatible with ICU Medical MedNet Software Refurb, Plum 360 sistema infusionale compatibile con ICU Medical MedNet Software, Pompe a perfusion Plum 360, compatible avec le logiciel ICU Medical MedNet
FDA Recall
Open, Classified
·ICU Medical Inc·Product code FRN·May 7, 2024
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FPA·March 16, 2021
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger, REF: CL3951; 40" (102 cm) Appx 7.7 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Bag Hanger, REF: CL3962; 31" (79 cm) Appx 3.5 ml, Admin Set w/ChemoLock Bag Spike with Additive Port, 20 Drop In-Line Chamber w/15 Micron Filter, Spiros, Purple Cap, Hanger, REF: CL3999
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code ONB·August 31, 2020
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
FDA Recall
Open, Classified
·ICU Medical, Inc.·Product code FJK·August 31, 2020
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
FDA Recall
Open, Classified
·ICU Medical Inc.·Product code FPA·August 6, 2025