BEUDAMED
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    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062

    FDA Recall
    Open, Classified ·Spectranetics Corporation·Product code QCT·January 10, 2025

    cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·January 20, 2026

    Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS

    FDA Recall
    Open, Classified ·Alcon Research, LLC·Product code LRO·June 9, 2022

    Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0 Product Usage: A topical gel that increases sexual excitement and pleasure.

    FDA Recall
    Open, Classified ·Altasource LLC dba Meta Labs LLC·Product code NA·February 3, 2014

    GEN LAPAROSCOPY PACK. Medical convenience kit.

    FDA Recall
    Open, Classified ·AVID Medical, Inc.·Product code LRO·June 11, 2025

    2008T GEN 2 Bibag without CDX

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023

    Contour next GEN Blood Glucose Monitoring System

    FDA Recall
    Open, Classified ·Ascensia Diabetes Care US, Inc.·Product code NBW·May 19, 2023

    Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M; 10) NEW LONDON MINOR CDS, Model Number: CDS982518M; 11) NEW LONDON MINOR CDS, Model Number: CDS982518N; 12) NEW LONDON MINOR CDS, Model Number: CDS982518O; 13) NEW LONDON MINOR CDS, Model Number: CDS982518P; 14) GENERAL LAPAROSCOPY CDS, Model Number: CDS983311J; 15) LAVH CDS, Model Number: CDS983411G; 16) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244J; 17) ROBOTIC-LF, Model Number: CDS984543C; 18) CYSTO CDS, Model Number: CDS984592G; 19) CYSTO CDS, Model Number: CDS984592I; 20) ROBOTIC, Model Number: CDS985270F; 21) GENERAL LAPAROSCOPY CDS, Model Number: CDS985422I; 22) ROBOTIC CDS, Model Number: CDS985429L; 23) LAP CHOLE CDS, Model Number: CDS985558N; 24) LAP CHOLE CDS, Model Number: CDS985558O; 25) ENDO KIT, Model Number: DYKE1580A; 26) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105; 27) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105A; 28) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105B; 29) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116; 30) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116B; 31) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117A; 32) KIT SURG ONC DIAGNOSTIC LAPARO, Model Number: DYKMBNDL12; 33) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121; 34) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121A; 35) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121B; 36) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121C; 37) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121F; 38) KIT L&D CYSTO SETUP, Model Number: DYKMBNDL135A; 39) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136; 40) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136A; 41) KIT THORACIC STAGING LAPAROTOM, Model Number: DYKMBNDL15; 42) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153A; 43) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153B; 44) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173; 45) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173A; 46) KIT THORACIC HIATAL HERNIA TRA, Model Number: DYKMBNDL175; 47) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176; 48) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176A; 49) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176B; 50) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176C; 51) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184; 52) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184A; 53) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188A; 54) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193; 55) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193A; 56) KIT UROLOGY BUCCAL GRAFT, Model Number: DYKMBNDL206; 57) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; 58) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60; 59) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60A; 60) KIT UROLOGY MINOR, Model Number: DYKMBNDL61A; 61) KIT UROLOGY MINOR, Model Number: DYKMBNDL61B; 62) KIT GEN SURG LAP COLECTOMY, Model Number: DYKMBNDL73; 63) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73A; 64) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73B; 65) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73C; 66) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73D; 67) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74; 68) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74A; 69) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74B; 70) KIT GEN SURG LAP GASTRIC BYPAS,

    FDA Recall
    Open, Classified ·Product code FDE·January 7, 2026

    NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176

    FDA Recall
    Open, Classified ·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022

    NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184.

    FDA Recall
    Open, Classified ·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022

    NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183

    FDA Recall
    Open, Classified ·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022

    G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177

    FDA Recall
    Open, Classified ·Thor Photomedicine Ltd Watermeadow House Chesham United Kingdom·Product code ILY·September 13, 2022

    MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

    FDA Recall
    Open, Classified ·Medical Information Technology, Inc.·Product code JQP·February 5, 2025

    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code OCC·January 30, 2023

    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL

    FDA Recall
    Open, Classified ·THOR Photomedicine Ltd 2 Anglo Office Park Units 1 &; 67 White Lion Road Amersham United Kingdom·Product code ILY·November 20, 2023

    Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNS·August 26, 2022

    Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G CUH MINOR PACK-LF DYNJ60095B FREE FLAP CUSTOM PACK B DYNJ82736B FREE NIPPLE GRAFT DYNJ911160B GEN MINOR DYNJ900906L GEN SURG LAPAROSCOPY PACK DYNJ55248F GEN SURG MINOR PACK DYNJ69142F GENERAL LAP DYNJ61475A DYNJT3759 GENERAL LAP PACK DYNJ61515I DYNJT4452 GENERAL LAP PACK-LF DYNJ37208D GENERAL LAPAROSCOPY DYNJ905870G GENERAL LAPAROSCOPY PACK DYNJ17443T DYNJ45263B DYNJT4504 LAP CHOLE DYNJ45664D DYNJ912005 LAP CHOLE PACK DYNJ81695B LAP CHOLE PACK-LF DYNJ0614113C DYNJ0618369V LAP CHOLE PROCEDURE-LF CDS981184D LAP CHOLE RFD DYNJ906302F LAP CHOLE SURGICOUNT DYNJ45531G LAP CHOLE TOTE DYNJ908339F LAP GASTRIC BYPASS CDS CDS860146M LAP GASTRIC PACK DYNJ62065A LAP HERNIA RFD DYNJ906301F LAP PACK DYNJ38871J DYNJ51389A LAPAROSCOPIC CDS920082AC LAPAROSCOPIC PACK DYNJ52605K LAPAROSCOPIC PACK-LF PHS41736G LAPAROSCOPY PACK DYNJT8313 LAPAROSCOPY PACK-LF DYNJ02309D DYNJ0551175T LAPAROSCOPY UM RF DYNJ902324D LAPAROSCOPY-LF DYNJ903241B LAPAROTOMY PACK-LF DYNJ21091O LARGE ABDOMINAL PACK-LF PHS41737D LEX GENERAL LAPAROSCOPY DYNJ900969K MINOR GENERAL PACK DYNJT3884 MINOR PACK-LF DYNJ0105608I MINOR PK DYNJ61335D MINOR PROCEDURE CDS CDS981793G PEDIATRIC MOSES DYNJ58864B PK, GEN-LAPAROSCOPY DYNJ53837B RMC GENERAL LAPAROSCOPIC DYNJ907087C ROBOTIC GENERAL DYNJ906861D SM-GENERAL LAP PACK-LF DYNJ0780078W SMJ GENERAL ABDOMINAL PACK-LF DYNJ25765Q UOFL HOSP GENERAL LAPAROSCOPY DYNJ909321A

    FDA Recall
    Open, Classified ·Product code FDE·April 27, 2026

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.

    FDA Recall
    Open, Classified ·Product code OHD·February 27, 2026

    IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code JJE·April 26, 2021

    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4

    FDA Recall
    Open, Classified ·Cytrellis Biosystems, Inc.·Product code QAI·June 23, 2023