BEUDAMED
    39 results · 17ms · Sources: EU EUDAMED, US FDA

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    ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FAS·October 2, 2023

    HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applications. 64 Models: 1) A22201C 2) A22201D 3) A22202C 4) A22203C 5) A22205C 6) A22205D 7) A22206C 8) A22207C 9) A22211C 10) A22221C 11) A22222C 12) A22223C 13) A22231C 14) A22231D 15) A22251C 16) A22253C 17) A22255C 18) A22257C 19) A22258C 20) A22266C 21) A44728C 22) WA22037C 23) WA22038C 24) WA22039C 25) WA22301D 26) WA22301S 27) WA22302D 28) WA22305D 29) WA22305S 30) WA22306D 31) WA22332D 32) WA22351C 33) WA22355C 34) WA22503D 35) WA22507D 36) WA22521C 37) WA22523C 38) WA22537D 39) WA22538C 40) WA22539D 41) WA22540S 42) WA22541S 43) WA22542S 44) WA22544S 45) WA22557C 46) WA22566S 47) WA22602D 48) WA22603D 49) WA22606D 50) WA22607D 51) WA22621C 52) WA22623C 53) WA22632D 54) WA22651C 55) WA22655C 56) WA22657C 57) WA47505S 58) WA47506S 59) WA47507S 60) WA47540S 61) WA47551S 62) WA47555S 63) WA47560S 64) WA47566S

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FAS·June 8, 2023

    Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. The AltiVate Reverse Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: " Severe arthropathy with a grossly deficient rotator cuff; " Previously failed joint replacement with a grossly deficient rotator cuff; " Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; " Bone defect in proximal humerus; " Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; " Inflammatory arthritis including rheumatoid arthritis; " Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP Monoblock and AltiVate Reverse humeral stems are intended for cemented or cementless use. Enovis" instrumentation consists of devices and their accessories used in surgical procedures. Implantation of Enovis" products should only be performed with Enovis" instrumentation or instrumentation distributed by Enovis". Enovis" instruments and instrument cases are generally composed of titanium, stainless steel, aluminum, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing the cleaning, sterilization, and drying cycle that has been validated and detailed below. Instrument cases do not provide a sterile barrier and must be used in conjunction with FDA cleared sterilization wrap to maintain sterility. Instruments are provided non-sterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below. Component: NA

    FDA Recall
    Open, Classified ·Product code FSM·July 18, 2025

    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

    FDA Recall
    Open, Classified ·C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden·Product code IYE·April 22, 2025

    General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

    FDA Recall
    Open, Classified ·Cypress Medical Products LLC·Product code FMF·August 6, 2024

    Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026

    IQon Spectral CT; Product Code (REF): 728332;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

    Spectral CT 7500 on Rails; Product Code (REF): 728334;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

    Brilliance iCT; Product Code (REF): 728306;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

    Spectral CT; Product Code (REF): 728333;

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

    Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZZ·February 20, 2019

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PGI·February 20, 2019

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code NJR·February 20, 2019

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZE·February 20, 2019

    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZN·February 20, 2019

    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PGX·February 20, 2019

    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·December 19, 2024