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    Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire

    FDA Recall
    Completed ·EYE COMFORT CARE LLC·Product code IRT·February 8, 2024

    Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code OYK·November 17, 2011

    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    FDA Recall
    Open, Classified ·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020

    Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP

    FDA Recall
    Open, Classified ·Alcon Research, LLC·Product code LRO·March 10, 2023

    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·April 4, 2016

    Medical convenience kits Item Number/Description BFCT04X CATARACT PACK - 205986 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 CMEY17AI EYE PACK - 213187 PERP25AQ PEI RETINAL PACK-206025 RFEY50AC EYE PACK-206026 UIVT47AS VITRECTOMY SUPPLY

    FDA Recall
    Open, Classified ·American Contract Systems Inc.·Product code OJK·September 4, 2025

    Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pack Number DYNJ83699A ; 7) BYERS CATARACT, Pack Number DYNJ67344; 8) BYERS CATARACT, Pack Number DYNJ67344H ; 9) CATARACT, Pack Number DYNJ44544B ; 10) CATARACT, Pack Number DYNJ54713C ; 11) CATARACT CDS , Pack Number CDS983804F ; 12) CATARACT CDS, Pack Number CDS983804F ; 13) CATARACT DR MALONE PACK , Pack Number DYNJ51590A ; 14) CATARACT DR MULROONEY PACK, Pack Number DYNJ51595A ; 15) CATARACT DR STEVENS PACK, Pack Number DYNJ51593C ; 16) CATARACT L J, Pack Number DYNJ40056A ; 17) CATARACT PACK, Pack Number CMPJ03235C ; 18) CATARACT PACK, Pack Number DYNJ80316A ; 19) CATARACT PACK, Pack Number VAL011CTASF; 20) CATARACT PACK , Pack Number CMPJ03235C ; 21) CATARACT PACK , Pack Number DYNJ31020K ; 22) CATARACT PACK , Pack Number DYNJ31020L ; 23) CATARACT PACK , Pack Number DYNJ54790D ; 24) CATARACT PACK , Pack Number DYNJ64962; 25) CATARACT PACK , Pack Number DYNJ80316; 26) CATARACT PACK , Pack Number DYNJ80316A ; 27) CATARACT PACK , Pack Number DYNJ80487A ; 28) CATARACT PACK , Pack Number DYNJ80487B ; 29) CATARACT PACK , Pack Number DYNJ80487C ; 30) CATARACT PACK , Pack Number DYNJ80487F ; 31) CATARACT PACK , Pack Number DYNJ84265A ; 32) CATARACT PACK , Pack Number DYNJ85332; 33) CATARACT PACK , Pack Number LYN042CPFEG; 34) CATARACT PACK , Pack Number VAL011CTASF; 35) CATARACT PACK , Pack Number DYNJ43048K ; 36) CATARACT PACK , Pack Number DYNJ52649D ; 37) CATARACT PACK , Pack Number DYNJ52649F ; 38) CATARACT PACK , Pack Number DYNJ55682D ; 39) CATARACT PACK , Pack Number DYNJ63284A ; 40) CATARACT PACK , Pack Number DYNJ63284B ; 41) CATARACT PACK , Pack Number DYNJ66410B ; 42) CATARACT PACK , Pack Number DYNJ85042; 43) CATARACT PACK , Pack Number DYNJ68836B ; 44) CATARACT PACK - GB, Pack Number DYNJ54790F ; 45) CATARACT PACK LUTHER HOSPITAL , Pack Number DYNJ61699D ; 46) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232; 47) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232H ; 48) CATARACT PACK-LF, Pack Number DYNJ42830D ; 49) CATARACT PACK-LF, Pack Number DYNJ0200004B ; 50) CATARACT PACK-LF, Pack Number DYNJ36100C ; 51) CATARACT TRAY , Pack Number DYNJ44356I ; 52) CATARACT TRAY , Pack Number DYNJ44356J ; 53) CATARACT TRAY , Pack Number DYNJ62410A ; 54) COVENANT RETINAL TRAY , Pack Number EYT102K; 55) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 56) CUSTOM EYE TRAY #1, Pack Number DYNJ66003C ; 57) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 58) CUSTOM EYE TRAY #2 , Pack Number DYNJ66004B ; 59) CUSTOM EYE TRAY #2, Pack Number DYNJ66004A ; 60) CUSTOM EYE TRAY #2, Pack Number DYNJ66004B ; 61) DDD VITRECTOMY PACK-LF, Pack Number DYNJ19973S ; 62) DR FLOOD EYE PACK , Pack Number DYNJ57258G ; 63) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671C ; 64) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671D ; 65) EYE , Pack Number DYNJ0559863K ; 66) EYE BCS PACK, Pack Number DYNJ37682J ; 67) EYE BCS PACK, Pack Number DYNJ37682K ; 68) EYE CATARACT (BASIC EYE), Pack Number DYNJ63272B ; 69) EYE INJECTION KIT , Pack Number MNS13080 ; 70) EYE MUSCLE PACK , Pack Number DYNJ66022A ; 71) EYE MUSCLE TRAY FFX , Pack Number DYNJ63638A ; 72) EYE PACK, Pack Number DYNJ40135C ; 73) EYE PACK, Pack Number DYNJ55484A ; 74) EYE PACK, Pack Number DYNJ60960A ; 75) EYE PACK, Pack Number DYNJ67973B ; 76) EYE PACK, Pack Number DYNJ83799C ; 77) EYE PACK, Pack Number VAL013EPWEC; 78) EYE PACK, Pack Number VAL038BSCLC; 79) EYE PACK, Pack Number DYNJ56293D ; 80) EYE PACK, Pack Number DYNJ64051C ; 81) EYE PACK, Pack Number CMPJ06528F ; 82) EYE PACK, Pack Number DYNJ38400I ; 83) EYE PACK, Pack Number DYNJ38400J ; 84) EYE PACK, Pack Number DYNJ64284C ; 85) EYE PACK, Pack Number DYNJ64284D ; 86) EYE PACK, Pack Numbe

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

    Sterile Procedural Trays, labeled as the following: a. BASIC EYE PACK-LF b. VITRECTOMY PACK-LF c. EYE PACK-EAST-LF d. OSC OCULAR PLASTIC PACK-LF e. EYE PACK f. OCULOPLASTIC PACK g. EYE PLASTIC PACK h. PLASTIC EYE PACK i. DR H BLEPH PACK j. BLEPH PACK k. OPHTHALMOLOGY PACK l. OCULOPLASTIC PACK m. BLEPH PACK n. EYE PACK o. OCULAR PLASTIC PACK p. OCULOPLASTIC PACK

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJK·November 17, 2022

    First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet 3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 Deluxe Cabinet 3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLBCSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R 200 Person Deluxe Cabinet - Refill R508016 Eye Wash 4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet 316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36MDelmarva Power/ACEw/Logo R508016 Eye Wash4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC4 200 Person Deluxe Cabinet 4 Shelf R508016 Eye Wash4 oz. 32-000452-0000 K206140 CLX 100 Person Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV7SHStandard Cabinet Swing Out Door2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash

    FDA Recall
    Terminated ·Certified Safety Mfg Inc·Product code LRR·March 20, 2018

    Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT PACK, Pack Number DYNJ0417156G; 7) CATARACT PACK, Pack Number DYNJ60411A; 8) CATARACT PACK, Pack Number DYNJ52649F; 9) CATARACT PACK - 30843, Pack Number DYNJVB1076B; 10) CATARACT PACK-LF, Pack Number DYNJ0317858M; 11) CATARACT-LF, Pack Number DYNJ40081F; 12) ENT PACK, Pack Number DYNJ38916B; 13) EYE CATARACT PK, Pack Number DYNJ46557K; 14) EYE CATARACT PK, Pack Number DYNJ46557L; 15) EYE PACK, Pack Number DYNJ48800C; 16) EYE PACK, Pack Number DYNJ38494G; 17) EYE PACK, Pack Number DYNJ21134A; 18) EYE PACK 1, Pack Number DYNJHTEY01; 19) EYE PACK II-LF, Pack Number DYNJ50237A; 20) EYE PBM-LF, Pack Number DYNJ0190619G; 21) MZ GENERAL EYE PACK, Pack Number DYNJ66623A; 22) OCULAR PLASTICS, Pack Number DYNJ82032; 23) OPHTHALMOLOGY PACK, Pack Number DYNJ52885D; 24) OPHTHALMOLOGY PACK, Pack Number DYNJ52885F; 25) PK, OPHTH-RETINA, Pack Number DYNJ45046A; 26) PLASTIC PACK, Pack Number DYNJ82060A; 27) RETINAL DSC, Pack Number DYNJ68940A; 28) SMSC- EYE PACK HOSP&CLINIC-LF, Pack Number DYNJ0780084F; 29) STRABISMUS PACK-LF, Pack Number DYNJ0789014K; 30) RETINAL PACK, Pack Number LYN030REFCA; 31) EYE PACK WHITEWATER SC, Pack Number VAL038EPWSB

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJK·February 11, 2025

    Merge Eye Station and Merge Eye Care PACS.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·April 4, 2016

    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·March 28, 2016

    Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number: DYNJ85284; 6) PHACO PACK, Model Number: DYNJ44748I; 7) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 8) CHOG MINOR OPHTHALMIC PACK, Model Number: SYNJ10271B; 9) LIFESPAN VITRECTOMY PACK, Model Number: DYNJ80082; 10) DR KEYS EYE PACK 2, Model Number: DYNJ48256M; 11) VITRECTOMY PACK, Model Number: DYNJ55508B; 12) EYE PACK, Model Number: DYNJ63952A; 13) VITRECTOMY, Model Number: DYNJ67309C; 14) CATARACT PACK-MARY IMMACUL-LF, Model Number: DYNJ24516F; 15) DR FLOOD EYE PACK, Model Number: DYNJ57258G; 16) BLEPH PACK, Model Number: DYNJ67875; 17) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 18) EYE PLASTIC PACK, Model Number: DYNJ47859C; 19) OPHTHALMOLOGY PACK, Model Number: SYNJ10259A; 20) PLASTIC EYE, Model Number: DYNJ45667C; 21) BASIC EYE PACK, Model Number: DYNJ81548B; 22) WMC CATARACT PACK-LF, Model Number: DYNJ50653F; 23) BASIC CATARACT, Model Number: DYNJ41097A; 24) PK EYE, Model Number: DYNJ60631B; 25) EYE PLASTIC SURGERY PACK, Model Number: DYNJ44061; 26) CATARACT, Model Number: DYNJ44544F; 27) CATARACT PACK, Model Number: DYNJ49515D; 28) CATARACT PACK, Model Number: DYNJ35438F; 29) OPHTHALMIC PLASTIC PACK, Model Number: DYNJ55208A; 30) CATARACT PACK, Model Number: DYNJ81534B; 31) CATARACT PACK, Model Number: DYNJ49515D

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJK·March 3, 2025

    regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OJK·October 20, 2022

    Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

    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

    Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT PACK WRO-LF, REF DYNJ41861; 9) EYE PACK, REF DYNJ43911; 10) PHACO PACK, REF DYNJ44748I; 11) DR DRUMMOND EYE PACK, REF DYNJ45344G; 12) OPHTHALMIC PACK, REF DYNJ47275A; 13) CATARACT PACK, REF DYNJ49412B; 14) CATARACT PACK, REF DYNJ50948A; 15) CATARACT PACK, REF DYNJ50948A; 16) CATARACT DR MALONE PACK, REF DYNJ51590A; 17) CATARACT DR MALONE PACK, REF DYNJ51590A; 18) CUSTOM EYE TRAY, REF DYNJ51821B; 19) EYE SURGERY PACK, REF DYNJ53097C; 20) CATARACT KIT, REF DYNJ53944; 21) EYE PACK, REF DYNJ54847D; 22) PK, OPHTH-EYE, REF DYNJ55070B; 23) EYE PACK, REF DYNJ55320D; 24) PK, OPHTH-RETINA, REF DYNJ59253B; 25) RETINA PACK, REF DYNJ60515; 26) ASED KIT, REF DYNJ60745D; 27) CATARACT PACK, REF DYNJ61321B; 28) EYE PACK, REF DYNJ61862A; 29) CATARACT PACK DR FREDERICK, REF DYNJ63163; 30) CATARACT DR ESTOPINAL, REF DYNJ63164; 31) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 32) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 33) HMSL EYE PACK, REF DYNJ64537A; 34) EYE PACK, REF DYNJ65271C; 35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832; 36) BASIC CATARACT PACK, REF DYNJ69165D; 37) BASIC CATARACT PACK, REF DYNJ69165D; 38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082; 39) CATARACT PACK WITH NO TUB, REF DYNJ80232; 40) RETINA PACK, REF DYNJ80483; 41) RETINA PACK, REF DYNJ81640; 42) WESTFALL OCCUPLASTY, REF DYNJ81796A; 43) EYE PACK, REF DYNJ83799C; 44) OPHTHALMIC PACK, REF DYNJ85275; 45) CATARACT, REF DYNJ908059A; 46) EYE TRAY 1-LF, REF LLSCAEYE01A; 47) PHACO PACK, REF LYN011PHNHD; 48) PHACO PACK, REF LYN011PHNHD; 49) SPECIALTY BESSER PACK, REF LYN023BPSSD; 50) SPECIALTY BESSER PACK, REF LYN023BPSSD; 51) SPECIALTY BESSER PACK, REF LYN023BPSSD; 52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 54) OPHTHALMIC PACK, REF LYN023OPSOB; 55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB; 56) BASIC CATARACT PACK, REF LYN030BCSDB; 57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA; 58) AIKEN CATARACT PACK II, REF LYN030CTAKG; 59) AIKEN CATARACT PACK II, REF LYN030CTAKG; 60) AIKEN CATARACT PACK II, REF LYN030CTAKG; 61) VA EYE II-LF, REF LYN030VAEYA; 62) VA EYE II-LF, REF LYN030VAEYA; 63) CATARACT PACK, REF LYN035CTSEC; 64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 66) OPHTHALMIC PACK, REF LYN041OPFCC; 67) OPHTHALMIC PACK, REF LYN041OPFCC; 68) OPHTHALMIC PACK, REF LYN041OPFCC; 69) OPHTHALMIC PACK, REF LYN041OPFCC; 70) CATARACT PACK, REF LYN042CPFEG; 71) OPTHALMIC PACK-LF, REF PHS529724000B; 72) CATARACT PACK, REF VAL001CPMEB; 73) CATARACT PACK, REF VAL001CPMEB; 74) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 75) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA; 77) CATARACT PACK, REF VAL009CAAHC; 78) RENAISSANCE CAT PACK, REF VAL009CAREA; 79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA; 80) CATARACT PACK, REF VAL009CTSGA; 81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC; 82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA; 83) RENAISSANCE VIT PACK, REF VAL009VIREA; 84) CATARACT PACK APERTURE, REF VAL011CTVAA; 85) OPHTHALMIC PACK, REF VAL022BSOMD; 86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD; 87) EYE PACK, REF VAL024EYTRB; 88) CATARACT PACK, REF VAL026CTNFC; 89) EYE PACK, REF VAL029EYGSB; 90) INTRAOCULAR PACK, REF VAL031IOGCB; 91) CATARACT, REF VAL035CPAEC; 92) CATARACT PACK 2, REF VAL036CABRD; 93) BRINTON VISION ICL PACK, REF VAL037ICBVG; 94) EYE PACK, REF VAL038BSCID; 95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB; 96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA; 97) BOOZMAN HOF PACK 2, REF VAL042EYBHC; 98) CATARACT PACK WILD

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJK·September 4, 2024

    Medline Convenience kits labeled as: 1) ADULT DRAWER 5, Pack Number ACC010647A ; 2) TUBAL LIGATION CDS, Pack Number CDS760053K ; 3) CATARACT CDS, Pack Number CDS810010J ; 4) CATARACT CDS, Pack Number CDS810010K ; 5) RETINA-LF, Pack Number CDS810023G; 6) RETINA-LF, Pack Number CDS810023I; 7) RETINA-LF, Pack Number CDS810023J; 8) RETINA-LF, Pack Number CDS810023K; 9) EYE CDS , Pack Number CDS810032L ; 10) EYE CDS , Pack Number CDS810032M ; 11) EYE CDS , Pack Number CDS810032N ; 12) EYE CDS , Pack Number CDS810032O ; 13) GENERAL EYE , Pack Number CDS981693I ; 14) GENERAL EYE , Pack Number CDS981693J ; 15) EYE CDS II, Pack Number CDS981738A ; 16) MUSCLE/EYE CDS, Pack Number CDS982059F ; 17) MUSCLE/EYE CDS, Pack Number CDS982059G ; 18) MUSCLE/EYE CDS, Pack Number CDS982059I ; 19) CATARACT CDS-4, Pack Number CDS983001F ; 20) VITRECTOMY CDS-4, Pack Number CDS983005F ; 21) PTERYGIUM CDS , Pack Number CDS983261D ; 22) PTERYGIUM CDS , Pack Number CDS983261F ; 23) PTERYGIUM CDS , Pack Number CDS983261G ; 24) PLASTIC EYE CDS-LF, Pack Number CDS983753C ; 25) PLASTIC EYE CDS-LF, Pack Number CDS983753D ; 26) RETINA LAC/USC CDS, Pack Number CDS983775I; 27) EYE CDS , Pack Number CDS983916F ; 28) EYE CDS , Pack Number CDS983916G ; 29) CATH CDS, Pack Number CDS984141G ; 30) CATARACT CDS, Pack Number CDS984159C ; 31) CATARACT CDS, Pack Number CDS984159D ; 32) CATARACT CDS, Pack Number CDS984159G ; 33) CATARACT CDS, Pack Number CDS984159I ; 34) VITRECTOMY, Pack Number CDS984258J ; 35) VITRECTOMY, Pack Number CDS984258K ; 36) VITRECTOMY, Pack Number CDS984258L ; 37) CATARACT CDS, Pack Number CDS984343B ; 38) CATARACT CDS, Pack Number CDS984343C ; 39) KIT SURG ONC MINOR, Pack Number DYKMBNDL6B ; 40) KIT SURG ONC MINOR, Pack Number DYKMBNDL6BH; 41) EYE BANK PREP KIT , Pack Number DYNDA2345; 42) LASIK PACK, Pack Number DYNDA2925; 43) EYE PLASTIC KIT, Pack Number DYNDC3196; 44) BIOPSY TRAY , Pack Number DYNDH1854; 45) LACERATION TRAY , Pack Number DYNDL1990; 46) LASIK PACK, Pack Number DYNDM1087; 47) GLENNON EYE PACK, Pack Number DYNJ00098F ; 48) CATARACT PACK , Pack Number DYNJ00260K ; 49) INTRAOCULAR PACK, Pack Number DYNJ00260L ; 50) INTRAOCULAR PACK, Pack Number DYNJ00260M ; 51) EYEPACK , Pack Number DYNJ00874G ; 52) EYEPACK , Pack Number DYNJ00874I ; 53) EYEPACK , Pack Number DYNJ00874J ; 54) EYEPACK , Pack Number DYNJ00874K ; 55) MEC EYE PACK, Pack Number DYNJ0101578F ; 56) MEC EYE PACK, Pack Number DYNJ0101578G ; 57) MEC EYE PACK, Pack Number DYNJ0101578J ; 58) BR EYE PAC, Pack Number DYNJ0101578K ; 59) BR EYE PACK-LF, Pack Number DYNJ0101578L ; 60) CATARACT TRACE PACK-LF, Pack Number DYNJ0101664D ; 61) PEN CATARACT PACK-LF, Pack Number DYNJ0101802D ; 62) PEN CATARACT PACK-LF, Pack Number DYNJ0101802F ; 63) PEN CATARACT PACK-LF, Pack Number DYNJ0101802G ; 64) PEN CATARACT PACK-LF, Pack Number DYNJ0101802I ; 65) PEN CATARACT PACK-LF, Pack Number DYNJ0101802J ; 66) PEN CATARACT PACK-LF, Pack Number DYNJ0101802K ; 67) PEN CATARACT PACK-LF, Pack Number DYNJ0101802L ; 68) PEN CATARACT PACK-LF, Pack Number DYNJ0101802M ; 69) CATARACT PACK , Pack Number DYNJ01263G ; 70) CATARACT PACK , Pack Number DYNJ01263I ; 71) CATARACT PACK , Pack Number DYNJ01263J ; 72) CATARACT PACK-LF, Pack Number DYNJ0129784R ; 73) CATARACT PACK-LF, Pack Number DYNJ0129784RH; 74) TRAY DR. WHITE'S EYE, Pack Number DYNJ0132717F ; 75) PK, OPHTH-EYE-WHITE , Pack Number DYNJ0132717G ; 76) CORNEAL TRANSPLANT PACK , Pack Number DYNJ0141239Q ; 77) RETINAL PACK-LF , Pack Number DYNJ0151148B ; 78) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122I ; 79) CORNEA (JSI) PACK-LF, Pack Number DYNJ0159122J ; 80) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122K ; 81) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122L ; 82) JSI-CORNEA PACK-LF, Pack Number DYNJ0159122M ; 83) CATARACT PACK-LF, Pack Number DYNJ0159809B ; 84) EYE PACK, Pack Number DYNJ0168810Q ; 85) EYE PBM-LF, Pack Number DYNJ0190619F ; 86) EYE PBM-LF, Pack Num

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

    NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI).

    FDA Recall
    Open, Classified ·NeuroSync, Inc.·Product code QEA·September 19, 2023

    MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitoring Systems provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick and accurate alignment with the patient and secure positive or negative pressure level setting. The system also has been designed to provide for ease of patient transport through a compact design and antimicrobial hydrophobic vent feature that resists occlusion. Indications: The MoniTorr ICP system allows for drainage and monitoring of CSF from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF inpatients with infected CSF shunts, and to monitor ICP.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code JXG·April 8, 2019