BEUDAMED
    122 results · 13ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Open, Classified × Clear all

    GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis

    FDA Recall
    Open, Classified ·GE HEALTHCARE AUSTRIA GMBH & CO Tiefenbach 15 Pfaffing Austria·Product code IYN·December 22, 2023

    Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / QS6-BLXCX: f) QS6 AM12Q TMX SYS Z200 PCRT AHA XML / QS6-BLXC1: g) QS6 AM12Q TTL KIT AHA / QS-6AC-XXAXX: h) QS6 AM12Q TTL KIT AHA / QS-6AC-XXBXX: i) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXAXA: j) QS6 AM12Q TTL KIT AHA DICOM / QS6-AXTDS: k) QS6 AM12Q TTL KIT AHA XML / QS-6AC-AXAAA: l) QS6 AM12Q TTL KIT AHA XML / QS-6AC-XXBXA: m) QS6 AM12Q TTL KIT AHA XML / QS-6AC-CXBXA: n) QS6 AM12Q TTL KIT AHA XML / QS-6AC-DXAXA: o) QS6 AM12Q TTL KIT AHA XML / QS6-MXTCS: p) QS6 AM12Q TTL KIT BCRT AHA DICOM / QS-6AC-CGAAB: q) QS6 AM12Q TTL KIT Z200 AHA XML / QS-6AC-XAAXA: r) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-EEBXX: s) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DFAAX: t) QS6 AM12Q TTL KIT Z200 BCRT AHA / QS-6AC-DEAAX: u) QS6 AM12Q TTL KIT Z200 BCRT AHA DICOM / QS-6AC-CFBAB: v) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFBAA: w) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFBAA: x) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-CFAAA: y) QS6 AM12Q TTL KIT Z200 BCRT AHA XML / QS-6AC-DFAAA: z) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CECAA: aa) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-AFCXA: bb) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFEAA: cc) QS6 AM12Q TTL KIT Z200 BCRT IEC XML / QS-6AC-CFCAA: dd) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-ACAAB: ee) QS6 AM12Q TTL KIT Z200 PCRT AHA DICOM / QS-6AC-DDBAB: ff) QS6 AM12Q TTL KIT Z200 PCRT AHA SVR / QS-6AC-DDBAC: gg) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-CDBXA: hh) QS6 AM12Q TTL KIT Z200 PCRT AHA XML / QS-6AC-DDBAA: ii) QS6 AM12Q TTL SYS AHA XML / QS-6AB-BXAXA: jj) QS6 AM12Q TTL SYS BCRT AHA DICOM / QS-6AB-CGAAB: kk) QS6 AM12Q TTL SYS Z200 BCRT AHA / QS-6AA-DEAXX: ll) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AB-CEAAA: mm) QS6 AM12Q TTL SYS Z200 BCRT AHA XML / QS-6AD-AEAAA: nn) QS6 AM12Q TTL SYS Z200 PCRT AHA / QS-6AD-BCAAX: oo) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-ACAAB: pp) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS-6AA-DDAAB: qq) QS6 AM12Q TTL SYS Z200 PCRT AHA DICOM / QS6-ATTDX: rr) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS-6AA-XCAAA: ss) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MLTCX: tt) QS6 AM12Q TTL SYS Z200 PCRT AHA XML / QS6-MTTCX: uu) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-CDCAA: vv) QS6 AM12Q TTL SYS Z200 PCRT IEC XML / QS-6AA-DDCAA: ww) QS6 AM12Q TTL TMX KIT BCRT AHA XML / QS-6BC-CGAAA: xx) QS6 AM12Q TTL TMX KIT Z200 PCRT IEC XML / QS-6BC-CDCXA: yy) QS6 AM12Q TTL TMX SYS Z200 BCRT AHA DIC / QS-6BB-CFAAB: zz) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BD-ACAAB: aaa) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS-6BA-ACAAB: bbb) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA DIC / QS6-ATTD1: ccc) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACAAA: ddd) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-DDDAA: eee) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS-6BA-ACBAA: fff) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MLTC1: ggg) QS6 AM12Q TTL TMX SYS Z200 PCRT AHA XML / QS6-MTTC1: hhh) QS6 AM12QKIT AHA XML / QS-6CC-XXAXA: iii) QS6 AM12QKIT AHA / QS-6CC-XXBXX: jjj) QS6 AM12QKIT BCRT AHA DICOM / QS-6CC-XGAAB: kkk) QS6 AM12QKIT BCRT IEC / QS-6CC-DGCAX: lll) QS6 AM12QKIT Z200 AHA / QS-6CC-XAAXX: mmm) QS6 AM12QKIT Z200 BCRT IEC / QS-6CC-DFCAX: nnn) QS6 AM12QSYS BCRT IEC XML / QS-6CA-DGCAA: ooo) QS6 AM12QSYS IEC XML / QS-6CB-CXCXA: ppp) QS6 AM12QSYS Z200 BCRT IEC / QS-6CB-DFCAX: qqq) QS6 AM12QSYS Z200 BCRT IEC XML / QS-6CA-DFCAA: rrr) QS6 NOACQMOD KIT NO LDSET XML / QS-6XC-XXXXA: sss) QS6 NOACQMOD KIT NO LDSET / QS-6XC-BXXXX: ttt) QS6 NOACQMOD KIT NO LDSET DICOM / QS-6XC-XXXXB: uuu) QS6 NOACQMOD SYS Z200 BCRT NO LDSET XML / QS-6XA-DFXAA: vvv) QS6 PRO ENHANCED SECURITY / QS6-STTDX: www)

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DPS·December 8, 2023

    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