128 results
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Sources: EU EUDAMED, US FDA
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ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.
FDA Recall
Open, Classified
·Stryker Howmedica Osteonics Corp.·Product code MEH·April 30, 2012
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
FDA Recall
Open, Classified
·LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany·Product code IEO·November 20, 2023
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
FDA Recall
Open, Classified
·Leica Biosystems Melbourne Pty Ltd·Product code IEO·April 2, 2025
Nussloch GmbH ASP6025 Tissue Processor
FDA Recall
Open, Classified
·Leica Microsystems, Inc.·Product code IEO·June 19, 2017
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
FDA Recall
Open, Classified
·LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany·Product code IEO·April 10, 2024
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