BEUDAMED
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    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)

    FDA Recall
    Terminated ·Caption Health·Product code QIH·May 19, 2021

    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free*** Distributed by: Cardinal Health McGaw Park, IL***.'

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FAP·December 13, 2005

    Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product SKU MH00002T The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

    FDA Recall
    Terminated ·Cardinal Health·Product code MPO·June 9, 2021

    Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product SKU MH00002N The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the pouch causing an exothermic chemical reaction, warming the pouch, which is then applied to the heel of an infant to aid in blood draws

    FDA Recall
    Terminated ·Cardinal Health·Product code MPO·June 9, 2021

    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FAP·December 13, 2005

    3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code LWK·January 12, 2024

    3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code LWK·January 12, 2024

    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

    Cardinal Health INSULATED GEL PACK REUSABLE, SMALL, Cat. 80204A

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    Cardinal Health HOT AND COLD GEL PACK REUSABLE, M, Cat. 70304

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    Cardinal Health INSULATED GEL PACK REUSABLE, MEDIUM, Cat. 80304A

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    Cardinal Health INSULATED GEL PACK REUSABLE, LARGE, Cat. 80104

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    Cardinal Health GEL PACK REUSABLE, SMALL, Cat. 70204

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    Cardinal Health INSULATED GEL PACK REUSABLE, EXTRA LARGE, Cat. 80600

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code IME·September 28, 2022

    3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code LWK·January 14, 2019

    Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028. The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table.

    FDA Recall
    Terminated ·Stryker Communications Corp·Product code FQO·May 8, 2009

    URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FBN·December 12, 2016

    VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·March 3, 2022