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    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.

    FDA Recall
    Terminated ·Cisco Systems Inc·Product code NSX·July 23, 2012

    Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code KDD·November 15, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CAROTID, Model Number: DYNJ54287A; b. CAROTID PACK, Model Number: DYNJ66190; c. CAROTID SUPPLY, Model Number: DYNJ905622C; d. CAROTID-LF, Model Number: DYNJ901745J; e. CENTRAL LINE INSERTION, Model Number: DYNJ63347A; f. CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; g. DBD-CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; h. DBD-IR THYROID PACK THLUF642-LF, Model Number: DYNJ47716B; i. ENT FREE FLAP, Model Number: SYNJ910018A; j. ENT FREE FLAP PACK, Model Number: DYNJ67954A; k. FEM CAROTID PACK, Model Number: DYNJ65706; l. FLAP ENT FREE, Model Number: DYNJ905340A; m. FREE FLAP PACK-LF, Model Number: DYNJ20495J; n. PACK HEAD NECK, Model Number: DYNJ30245; o. SVMMC CAROTID PACK, Model Number: DYNJ43861D; p. TAVR FAIRFAX, Model Number: DYNJ63634A; q. VNUS TRAY, Model Number: DYNJ44410F;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGR·May 15, 2023

    See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B;

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

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PACK, Model Number DYNJ30245; c) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716B; d) CENTRAL LINE INSERTION, Model Number DYNJ63347A; e) TAVR FAIRFAX, Model Number DYNJ63634A; f) PARATHYROID PACK, Model Number DYNJ81389A; g) THYRIOD PACK, Model Number DYNJ83960; h) WMC COCHLEAR IMPLANT ADD ON, Model Number DYNJ907206D

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGR·May 18, 2023

    Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTESIS KIT/AK-01000-T, THORACENTESIS KIT/AK-01000, THORACENTESIS KIT/ASK-01000-CHP, DRAINAGE KIT/ASK-01000-NW, THORACENTESIS KIT/ASK-01000-UPMS, PNEUMOTHORAX KIT/AK-01500, PNEUMOTHORAX KIT (NO HEIMLICH VALVE)/ASK-01500, PNEUMOTHORAX KIT/ASK-01500-JCM

    FDA Recall
    Open, Classified ·ARROW INTERNATIONAL, LLC·Product code PAD·April 21, 2026

    Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ; 6) CAROTID CDS-LF, Pack Number CDS840056N ; 7) CAROTID-LF, Pack Number CDS860039J ; 8) T & A PROCEDURE-LF, Pack Number CDS860047X ; 9) THORACOTOMY CDS , Pack Number CDS920065R ; 10) EAR CDS , Pack Number CDS980089L ; 11) EAR CDS , Pack Number CDS980089M ; 12) EAR CDS , Pack Number CDS980089N ; 13) EAR CDS , Pack Number CDS980089O ; 14) ENDOSCOPY , Pack Number CDS980201R ; 15) TYMPANOPLASTY , Pack Number CDS980203R ; 16) TYMPANOPLASTY , Pack Number CDS980203S ; 17) TYMPANO CDS , Pack Number CDS980374M ; 18) TYMPANO CDS , Pack Number CDS980374O ; 19) TYMPANO CDS , Pack Number CDS980374P ; 20) THORACOTOMY CDS , Pack Number CDS980446T ; 21) SINUS CDS , Pack Number CDS980579D ; 22) EENT-HEAD AND NECK, Pack Number CDS980809K ; 23) EENT-HEAD AND NECK, Pack Number CDS980809L ; 24) EENT-HEAD AND NECK, Pack Number CDS980809M ; 25) FESS PROCEDURE, Pack Number CDS981185B ; 26) CDS981571P, Pack Number CDS981571P ; 27) SINUS CDS-LF, Pack Number CDS981692J ; 28) EAR CDS , Pack Number CDS981985F ; 29) MAJOR EAR , Pack Number CDS982016Q ; 30) MAJOR EAR , Pack Number CDS982016R ; 31) MAJOR EAR , Pack Number CDS982016S ; 32) MAJOR EAR , Pack Number CDS982016T ; 33) SINUS , Pack Number CDS982020O ; 34) SINUS , Pack Number CDS982020P ; 35) SINUS , Pack Number CDS982020R ; 36) NASAL/SEPTAL, Pack Number CDS982049M; 37) NASAL/SEPTAL, Pack Number CDS982049O; 38) T&A CDS-LF, Pack Number CDS982091I ; 39) EAR-EENT CDS, Pack Number CDS982307F ; 40) EAR-EENT CDS, Pack Number CDS982307G ; 41) EAR-EENT CDS, Pack Number CDS982307J ; 42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ; 43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ; 44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ; 45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ; 46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ; 47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ; 48) EAR CDS-LF, Pack Number CDS982612B ; 49) T AND A CDS MRH , Pack Number CDS982622L ; 50) CAROTID , Pack Number CDS982638J ; 51) NASAL CDS , Pack Number CDS982655C ; 52) NASAL CDS , Pack Number CDS982655D ; 53) NASAL CDS , Pack Number CDS982655F ; 54) NECK THYROID, Pack Number CDS982692M ; 55) NECK THYROID, Pack Number CDS982692N ; 56) NECK THYROID, Pack Number CDS982692O ; 57) TYMPANOPLASTY , Pack Number CDS982720N ; 58) TYMPANOPLASTY , Pack Number CDS982720P ; 59) TYMPANOPLASTY , Pack Number CDS982720Q ; 60) TYMPANOPLASTY , Pack Number CDS982720R ; 61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ; 62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ; 63) SINUS CDS-1 , Pack Number CDS982901F ; 64) MIDDLE EAR CDS, Pack Number CDS982938J ; 65) MIDDLE EAR CDS, Pack Number CDS982938K ; 66) MIDDLE EAR CDS, Pack Number CDS982938L ; 67) MIDDLE EAR CDS, Pack Number CDS982938O ; 68) SMR/RHINO CDS , Pack Number CDS982939L ; 69) SMR/RHINO CDS , Pack Number CDS982939M ; 70) SMR/RHINO CDS , Pack Number CDS982939N ; 71) SMR/RHINO CDS , Pack Number CDS982939Q ; 72) SMR/RHINO CDS , Pack Number CDS982939R ; 73) SMR/RHINO CDS , Pack Number CDS982939S ; 74) T&A CDS , Pack Number CDS982944J ; 75) T&A CDS , Pack Number CDS982944K ; 76) MINOR EAR , Pack Number CDS982989K ; 77) MINOR EAR , Pack Number CDS982989L ; 78) MINOR EAR , Pack Number CDS982989M ; 79) MINOR EAR , Pack Number CDS982989N ; 80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ; 81) ENT CDS , Pack Number CDS983035J ; 82) ENT CDS , Pack Number CDS983035L ; 83) ENT CDS , Pack Number CDS983035M ; 84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ; 85) CHP TYMPMASTOID CDS, Pack Number CDS983088J; 86) HEAD & NECK CDS , Pack Number CDS983126B ; 87) HEAD & NECK CDS , Pack Number CDS983126C ; 88) CAROTID CDS-

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGR·April 8, 2024

    Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B; 9) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174; 10) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174A; 11) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174B; 12) KIT PEDS HEAD AND NECK, Model Number: DYKMBNDL196; 13) KIT OMF LEFORTE, Model Number: DYKMBNDL1A; 14) KIT OMF LEFORTE, Model Number: DYKMBNDL1B; 15) KIT OMF LEFORTE, Model Number: DYKMBNDL1C; 16) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32; 17) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32A; 18) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32B; 19) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66A; 20) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66B; 21) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88A; 22) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88B; 23) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88C; 24) KIT GEN SURG LAP VENTRA, Model Number: DYKMBNDL96C; 25) MINOR ENT PACK, Model Number: DYNJ01831I; 26) ENT BASIC PACK-LF, Model Number: DYNJ0387711F; 27) D AND C PACK-LF, Model Number: DYNJ0855090P; 28) CSS SINUS PACK, Model Number: DYNJ17005I; 29) CSS HEAD & NECK PACK, Model Number: DYNJ26780I; 30) NASALPLASTY #61-RF, Model Number: DYNJ27320V; 31) MASTOID PACK-WINTER PARK-LF, Model Number: DYNJ32060C; 32) T&A PACK, Model Number: DYNJ32809I; 33) HEAD AND NECK PACK, Model Number: DYNJ41169; 34) SIMPLE NECK DISSECTION, Model Number: DYNJ47481C; 35) ENT PACK, Model Number: DYNJ47882F; 36) ENT PACK, Model Number: DYNJ48401C; 37) ENT PACK, Model Number: DYNJ51934A; 38) PK,ORTHO-EXTREMITY-LOSROBLES, Model Number: DYNJ52916A; 39) HEAD & NECK PACK, Model Number: DYNJ54964A; 40) HEAD & NECK PACK, Model Number: DYNJ54964B; 41) ENT - MINOR ENT PACK-LF, Model Number: DYNJ56840B; 42) GLENNON HEAD AND NECK PACK-LF, Model Number: DYNJ57200C; 43) ENT PACK, Model Number: DYNJ57688F; 44) RF T AND A PACK, Model Number: DYNJ61393A; 45) T & A PACK, Model Number: DYNJ61935D; 46) ENT PACK, Model Number: DYNJ62093B; 47) ENT PACK, Model Number: DYNJ64024B; 48) OSCLJ HEAD AND NECK PACK, Model Number: DYNJ66509A; 49) HEAD AND NECK PACK, Model Number: DYNJ67208; 50) HEAD & NECK PACK, Model Number: DYNJ67328B; 51) PEDS HEAD AND NECK PACK, Model Number: DYNJ69746B; 52) NASAL PACK, Model Number: DYNJ81280A; 53) ENT-PLASTICS PACK, Model Number: DYNJ84258A; 54) ENT-PLASTICS PACK, Model Number: DYNJ84258B; 55) HEAD & NECK PACK, Model Number: DYNJ85078A; 56) ENT PACK, Model Number: DYNJ86194A; 57) EENT PACK, Model Number: DYNJ86235; 58) ENT PACK, Model Number: DYNJ87378; 59) ENT PACK, Model Number: DYNJ87378A; 60) ENT PACK, Model Number: DYNJ87378D; 61) ENT SPLIT PACK, Model Number: DYNJ87451; 62) ENT SINUS PACK, Model Number: DYNJ88498; 63) NASAL, Model Number: DYNJ902993F; 64) ENDO SINUS-MIDTOWN, Model Number: DYNJ905866; 65) T A, Model Number: DYNJ906292B; 66) THYROID, Model Number: DYNJ906841A; 67) THYROID - SMH AMB, Model Number: DYNJ907739B; 68) ENT, Model Number: DYNJ911623; 69) HEAD AND NECK PACK, Model Number: DYNJT5739; 70) RO MEDIASTINAL PACK-LF, Model Number: PHS393087007C

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

    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol Reagent Pack and Calibrators on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems.

    FDA Recall
    Terminated ·ORTHO-CLINICAL DIAGNOSTICS FELINDRE MEADOWS Bridgend United Kingdom·Product code CHP·July 14, 2016

    Dimension Vista Estradiol (E2) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·March 21, 2017

    Alinity i Estradiol Reagent Kit, List Number 07P5020

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CHP·November 21, 2018

    ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code CHP·March 5, 2018

    Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer.

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CHP·February 5, 2019

    Access Immunoassay Systems Estradiol, Part Number: 33540 Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHP·March 4, 2010

    LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code CHP·July 13, 2016

    The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code CHP·March 24, 2016

    ARCHITECT Estradiol Reagent, each kit contains bottles of coated Microparticles and bottles of Conjugate; 400 Test Kit-list number 2K25-20 (4 x 100 tests) and 100 Test Kit-list number 2K25-25 (1 x 100 tests); Abbott Laboratories, Abbott Park, IL 60064-3500

    FDA Recall
    Terminated ·Abbott Laboratories·Product code CHP·February 19, 2007

    IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - Product Usage: For in vitro diagnostic use with the IMMULITE systems Analyzers for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·February 5, 2020

    Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·March 3, 2022

    Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995561 All lots

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CHP·March 3, 2022