BEUDAMED
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    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

    FDA Recall
    Open, Classified ·Koven Technology, Inc.·Product code DPW·March 4, 2026

    Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·December 8, 2025

    Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3

    FDA Recall
    Open, Classified ·Securitas Healthcare LLC·Product code IQA·December 8, 2025

    XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64

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

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO STERILE OPERATING SCISSOR 5.5" B/B C50,Model Number 94-1346; 5) ECONO STERILE MAYO SCISS STR 5.5" CS/50,Model Number 94-1925; 6) ECONO STERILE OR SCISSORS/FORCEP TRAY 50/CS,Model Number 94-4091; 7) ECONO STERILE WIRE SCISSORS SURGI-OR CS/50,Model Number 94-5692; 8) ECONO STERILE MAYO SCIS STR 6.75" STER CS/50,Model Number 94-6096; 9) ECONO STERILE MAYO SCIS CVD 6.75 STER CS/50,Model Number 94-6097; 10) ECONO STERILE UTILITY SCISS YELL ST CS25 7",Model Number 96-1220; 11) ECONO STERILE UTILITY SCISS ORNG ST CS25 7",Model Number 96-1221; 12) ECONO STERILE UTILITY SCISS PRPL ST CS25 7",Model Number 96-1222; 13) ECONO STERILE UTILITY SCISSOR MAG ST CS25 7",Model Number 96-1224; 14) ECONO STERILE UTILITY SCISSOR RYL ST CS25 7",Model Number 96-1226; 15) ECONO STERILE UTILITY SCISS LM GR ST CS25 7",Model Number 96-1228; 16) ECONO STERILE MAYO DISS SCISS STR 9" STER25,Model Number 96-2260; 17) ECONO STERILE MAYO DISS SCISS CV 9"STRLCS/25,Model Number 96-2261; 18) ECONO STERILE MAYO DISS SCISS CVD 9" STER25,Model Number 96-2261A; 19) ECONO STERILE METZENBAUM SCIS STR7"STRLCS/25,Model Number 96-2263A; 20) ECONO STERILE METZENBAUM SCIS STR9"STER CS25,Model Number 96-2266; 21) ECONO STERILE MAYO DISS SCISS CVD 5.5"CS/25,Model Number 96-2433; 22) ECONO STERILE MAYO DISS SCISS CVD 6.75"CS/25,Model Number 96-2435; 23) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437; 24) ECONO STERILE METZ-NELSON SCISS CVD 9" CS/25,Model Number 96-2437A; 25) ECONO STERILE IRIS SCISS CVD S/S 3.5" CS/25,Model Number 96-2471; 26) ECONO STERILE TOENAIL SCISS CVD 4.5" STER 25,Model Number 96-2492A; 27) ECONO STERILE IRIS SCIS CVD DEL 4 STER CS/25,Model Number 96-2494A; 28) ECONO STERILE IRIS SCIS STR LG RG 4.5 STER25,Model Number 96-2495A; 29) ECONO STERILE IRIS SCISS STR S/S 3.5" CS/25,Model Number 96-2496; 30) ECONO STERILE IRIS SCIS STR S/S 3.5 STER C50,Model Number 96-2497; 31) ECONO STERILE IRIS SCIS CVD S/S 3.5 STER C50,Model Number 96-2499; 32) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500; 33) ECONO STERILE LISTER BAND SCISS 7 1/4" CS/25,Model Number 96-2500A; 34) ECONO STERILE LISTER BAND SCISS 5.5 STER C50,Model Number 96-2502; 35) ECONO STERILE LISTER BAND SCIS STER 5 1/2 50,Model Number 96-2502M; 36) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503; 37) ECONO STERILE LISTER BAND SCIS STER 5 1/2 25,Model Number 96-2503A; 38) ECONO STERILE IRIS SCIS STR S/S 4.5 STER C50,Model Number 96-2504; 39) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505; 40) ECONO STERILE IRIS SCISS STR 4.5" STER CS/25,Model Number 96-2505A; 41) ECONO STERILE IRIS SCIS CVD S/S 4.5 STER C50,Model Number 96-2506; 42) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/50,Model Number 96-2506M; 43) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507; 44) ECONO STERILE IRIS SCISS CVD 4.5" STER CS/25,Model Number 96-2507A; 45) ECONO STERILE SPENCER ST SCIS DEL 3.5 STER25,Model Number 96-2511A; 46) ECONO STERILE LITT SUT SCIS 5 1/2 STER CS/50,Model Number 96-2512; 47) ECONO STERILE LITT SUT SCISS 5 1/2 STER CS25,Model Number 96-2513; 48) ECONO STERILE OR SCIS STR B/B 5.5" STER CS50,Model Number 96-2514; 49) ECONO STERILE METZ SCISS STR STER 5.5" CS/50,Model Number 96-2516; 50) ECONO STERILE METZ SCISS STR STER 5.5" 25/CS,Model Number 96-2517; 51) ECONO STERILE METZ SCISS STRS 5.5" STER CS25,Model Number 96-2517A; 52) ECONO STERILE WIRE CUT SCIS ANG 4 3/4 STRL25,Model Number 96-2519; 53) ECONO STERILE OR SCISS STR S/B 5.5" STER C50,Model Number 96-2520; 54) ECONO STERILE OR SCIS STR S/B 5.5 STER CS50,Model Number 96-2520A;

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code LRW·December 3, 2024

    Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66150; e) STERILE STRT IRIS SCISSOR (IS163), Product Code 66155; f) STERILE LITTAUER SCISSOR (LI027), Product Code 66215; g) STERILE 5-1/2" S/S SCISSOR (SS507), Product Code 66260; h) STERILE STRT MAYO SCISSOR (ST129), Product Code 66350; i) STERILE CURV METZENBAUM SCISSOR (MBS141), Product Code 66365; j) STERILE SATIN IRIS SCISSOR (IS163S), Product Code 66450; k) STERILE SATIN CURV IRIS SCISSOR (IC164S), Product Code 66465; l) STERILE CURV MAYO SCISSOR 5 1/2" (81310), Product Code 66665; m) STERILE 4-1/2 S/B SATIN SCISSOR (I142S), Product Code 66710; n) STERILE 6 1/2" S/B SCISSOR (11109SB), Product Code 66820; o) STERILE FINE LITTAUER SCISSOR (#FLS35), Product Code 66845; p) STERILE 7 IN STRT METZ SCISSOR (SM007), Product Code 66885; q) STERILE CURVED IRIS SCISSOR (IC165), Product Code 66890; r) STERILE CURVED METZENBAUM (ST142), Product Code 66895; s) STERILE B/B SCISSOR 6 1/2", Product Code 66995; t) STERILE 6 3/4" MAYO SCISSOR, Product Code 67160; u) STERILE STRT METZENBAUM SCISSORS(MBS55), Product Code 67165; v) STERILE SATIN IRIS SCISSORS W/ LG LOOPS, Product Code 67185; w) STERILE SATIN CRVD IRIS SCISSOR (IC170S), Product Code 67450; x) STERILE 51/2" EPISIOTOMY SCISSOR (11140), Product Code 67645; y) STERILE STRABISMUS SCISSOR,CRVD(81485), Product Code 67650; z) STERILE REPROCESSED 6 1/2" S/B SCISSOR, Product Code 66820K; aa) ST METZENBAUM SCISSOR CURVED 9"(MBS90C), Product Code I68510; bb) ST UMBILICAL SCISSOR, CRVD, 4" (11148), Product Code I68575; cc) ST. CASTROVIEJO SCISSOR CURVED (503655), Product Code I68790; dd) STERILE CURV SCISSOR (SS510), Product Code TRI66600; ee) ST ANGLED BANDAGE SCISSOR REPROCESS, Product Code TRI66670K; ff) STERILE STR MAYO SCISSOR 5 1/2" (ST115), Product Code TRI67630 MEDLINE: MEDLINE manual surgical kits labeled as: a) O.R. SCISSORS, S/B, 5.5 STERILE, Product Code DYND04000; b) O R SCISSORS S/B 5.5 HG STERILE, Product Code DYND04133

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRW·February 23, 2024

    Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DTZ·September 12, 2025

    CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC

    FDA Recall
    Open, Classified ·Terumo Cardiovascular Systems Corporation·Product code DTZ·March 1, 2023

    QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000

    FDA Recall
    Open, Classified ·GETINGE US SALES LLC·Product code DTZ·November 13, 2019

    BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

    FDA Recall
    Open, Classified ·Cypress Medical Products LLC·Product code GTZ·August 20, 2024

    QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

    FDA Recall
    Open, Classified ·Medtronic Perfusion Systems·Product code DTZ·December 12, 2022

    BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·July 22, 2022

    QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 50100-USA 701067934 Small Adult without filter, with SOFTLINE Coating HMO 51100-USA 701067938 Small Adult with filter, with SOFTLINE Coating HMO 70100-USA 701067874 Adult without filter, with SOFTLINE Coating HMO 71100-USA 701067886 Adult with filter, with SOFTLINE Coating

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·May 18, 2023

    Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.

    FDA Recall
    Open, Classified ·Maquet Medical Systems USA·Product code DTZ·January 16, 2024