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    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

    FDA Recall
    Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and Novation GXL Liner, Lipped Ant, 28mm. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; Novation GXL Liner, G0, 28mm ID; Novation GXL Liner, Lipped Ant, 28mm; and Novation GXL Liner, Lipped, 28mm. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LPH·June 29, 2021

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53 d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54 e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55 f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53 g. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS, REF 136-32-54 h. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS, REF 136-32-55 i. NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS, REF 136-28-51 j. NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS, REF 136-32-51 k. NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS, REF 136-32-52 l. NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS, REF 136-36-52 m. NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS, REF 136-36-53 n. NOVATION GXL LINER, +5LAT, 36MM G4-60/62MM CUPS, REF 136-36-54 o. NOVATION GXL LINER, +5LAT, 36MM G5-64/66/68MM CUPS, REF 136-36-55 p. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 1 CUP, REF 138-32-51 q. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 3 CUP, REF 138-32-53 r. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 2 CUP, REF 138-36-52 s. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 3 CUP, REF 138-36-53 t. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 4 CUP, REF 138-36-54 u. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 5 CUP, REF 138-36-55 v. NOVATION GXL LINER, 10 DEG FACE, REPLACED BY 138-36-52, REF 138-32-52 w. NOVATION GXL LINER, LIPPED 32MM ID GROUP 2 CUPS, REF 132-32-52 x. NOVATION GXL LINER, LIPPED ANT, 32MM ID, GROUP 1 CUPS, REF 132-32-61 y. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 2 CUPS, REF 132-36-62 z. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 3 CUPS, REF 132-36-63 aa. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 4 CUPS, REF 132-36-64 bb. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 3 CUPS, REF 132-36-53 cc. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 1 CUPS, REF 132-28-51 dd. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 2 CUPS, REF 132-28-52 ee. NOVATION GXL LINER, LIPPED, 32MM ID GROUP 4 CUPS, REF 132-32-54 ff. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 3 CUPS, REF 132-32-53 gg. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 5 CUPS, REF 132-32-55 hh. NOVATION GXL LINER, LIPPED, 36MM ID GROUP 4 CUPS, REF 132-36-54 ii. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 5 CUPS, REF 132-36-55 jj. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 2 CUPS, REF 130-28-52 kk. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 3 CUPS, REF 130-32-53 ll. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 4 CUPS, REF 130-32-54 mm. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 5 CUPS, REF 130-32-55

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code LZO·August 11, 2022

    Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

    FDA Recall
    Open, Classified ·Intersect ENT, Inc.·Product code OWO·October 21, 2022

    WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. KIT TRIAGE ADMIT, Model Number: DYKA1456; b. KIT,ANTE PARTUM, Model Number: DYKL1844; c. MATERNAL ADMIT KIT, Model Number: DYKM2091

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

    MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905368B; 5) VP SHUNT PACK, Medline Kit Number/SKU DYNJ46530I.

    FDA Recall
    Open, Classified ·Product code OFF·May 4, 2026

    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code OJG·March 22, 2023

    Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W; 2) HAND/FOOT CDS, REF CDS984003A; 3) SPECIAL PROCEDURE PACK, REF DYNJ32639C; 4) PK-ORTHO-MINOR, REF DYNJ39547B; 5) ANT CERV ADD ON PACK, REF DYNJ41229C; 6) NAVIGATIONAL SPINE FUSION, REF DYNJ45153B; 7) FEET, ELBOW, AND ANKLE TEGH-LF, REF DYNJ46719B; 8) PLASTIC HAND PACK TEGH-LF, REF DYNJ46739B; 9) CVL INSERTION KIT-LF, REF DYNJ48587A; 10) CVL INSERTION KIT-LF, REF DYNJ48587A; 11) ENSEMBLE SURPLUS LCA-LF, REF DYNJ48892C; 12) EXTREMITY PACK, REF DYNJ49301B; 13) ACL ACCESSORY PACK, REF DYNJ50952F; 14) SPINAL INJECTION PACK, REF DYNJ51383F; 15) FTMC ARTHROS BASIC SETUP-LF, REF DYNJ54602A; 16) MINOR EXTREMITY PACK, REF DYNJ55324G; 17) MINOR EXTREMITY PACK, REF DYNJ55324G; 18) D-SPINE SUPPLEMENT PACK, REF DYNJ58115A; 19) EXTREMITY PACK, REF DYNJ62877; 20) AHT LG KNEE ROLL, REF DYNJ64823; 21) CUSTOM ORTHO PACK, REF DYNJ83675; 22) DR SUNDAR SCS KIT, REF DYNJ85288A; 23) CENTRAL SCS TRIAL PACK, REF DYNJ85503; 24) TOTAL KNEE CDS-LF, REF DYNJ909569; 25) EXTREMITY PACK, REF SYNJ10253B; 26) CARROLLTON HIP FX, REF SYNJ910003A; 27) ARTHROSCOPY, REF SYNJ910004C

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

    MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.

    FDA Recall
    Open, Classified ·Product code OJH·May 4, 2026

    Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC13 3) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC14 4) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC15 5) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC16 6) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC17 7) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC18 8) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC1D 9) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC22 10) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC23 11) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC24 12) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC25 13) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC26 14) CHI STD NEURO CRANI OPT 2, Catalog Number:CHIP99NC2C 15) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP32 16) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP33 17) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP34 18) CHI STD SPINE OPTION 3, Catalog Number:CHIP99SP3D 19) KIT, VP SHUNT, Catalog Number:P55VNVP09A 20) KIT,ANT CERVICAL DISK,MO BAP, Catalog Number:PGVMACMOQ 21) KIT, CRANIOTOMY, Catalog Number:PN11CNC10 22) KIT, CRANIOTOMY, Catalog Number:PN11CNC11 23) KIT, CRANIOTOMY, Catalog Number:PN11CNC12 24) KIT, CRANIOTOMY, Catalog Number:PN11CNC13 25) KIT, CRANIOTOMY, Catalog Number:PN11CNC14 26) KIT, CRANIOTOMY, Catalog Number:PN11CNC15 27) KIT, CRANIOTOMY, Catalog Number:PN11CNC16 28) KIT, CRANIOTOMY, Catalog Number:PN11CNC17 29) KIT, CRANIOTOMY, Catalog Number:PN11CNC18 30) KIT, CRANIOTOMY, Catalog Number:PN11CNC19 31) KIT, CRANIOTOMY, Catalog Number:PN11CNC20 32) KIT, CRANIOTOMY, Catalog Number:PN11CNCH7 33) KIT, CRANIOTOMY, Catalog Number:PN11CNCH8 34) KIT, CRANIOTOMY, Catalog Number:PN11CNCH9 35) KIT, CRANIOTOMY, Catalog Number:PN11CNCHN 36) KIT, CRANIOTOMY, Catalog Number:PN11CNCHO 37) KIT, CRANIOTOMY, Catalog Number:PN11CNCHQ 38) KIT, CRANIOTOMY, Catalog Number:PN11CNCHR 39) KIT, CRANIOTOMY, Catalog Number:PN11CNCHS 40) KIT, CRANIOTOMY, Catalog Number:PN11CNCHT 41) KIT, CRANIOTOMY, Catalog Number:PN11CNCHU 42) KIT, CRANIOTOMY, Catalog Number:PN11CNCHV 43) KIT, NEURO SJMC, Catalog Number:PN11NEXX2 44) KIT, NEURO SJMC, Catalog Number:PN11NEXX3 45) KIT, NEURO SJMC, Catalog Number:PN11NEXX4 46) KIT, NEURO SJMC, Catalog Number:PN11NEXX5 47) KIT, NEURO SJMC, Catalog Number:PN11NEXX6 48) KIT, NEURO SJMC, Catalog Number:PN11NEXX7 49) KIT, NEURO SJMC, Catalog Number:PN11NEXXB 50) KIT, NEURO SJMC, Catalog Number:PN11NEXXD 51) KIT, NEURO SJMC, Catalog Number:PN11NEXXE 52) KIT, NEURO, Catalog Number:PN11OTR10 53) KIT, NEURO, Catalog Number:PN11OTR11 54) KIT, NEURO, Catalog Number:PN11OTR12 55) KIT, NEURO, Catalog Number:PN11OTR13 56) KIT, NEURO, Catalog Number:PN11OTR14 57) KIT, NEURO, Catalog Number:PN11OTRM1 58) KIT, NEURO, Catalog Number:PN11OTRM2 59) KIT, NEURO, Catalog Number:PN11OTRM3 60) KIT, NEURO, Catalog Number:PN11OTRM4 61) KIT, NEURO, Catalog Number:PN11OTRM5 62) KIT, NEURO, Catalog Number:PN11OTRM7 63) KIT, NEURO, Catalog Number:PN11OTRM8 64) KIT, NEURO, Catalog Number:PN11OTRM9 65) NEURO, KIT, Catalog Number:PN11OTRMQ 66) KIT, NEURO, Catalog Number:PN11OTRMR 67) KIT, NEURO, Catalog Number:PN11OTRMS 68) KIT, NEURO, Catalog Number:PN11OTRMV 69) KIT, NEURO, Catalog Number:PN11OTRMW 70) KIT, SPINAL FUSION, Catalog Number:PN11SHCH5 71) KIT, SPINAL FUSION, Catalog Number:PN11SHCH6 72) KIT, SPINAL FUSION, Catalog Number:PN11SHCH7 73) KIT, SPINAL FUSION, Catalog Number:PN11SHCHQ 74) KIT, SPINAL FUSION, Catalog Number:PN11SHCHR 75) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR10 76) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR11 77) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR12 78) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR13 79) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR14 80) KIT, LARGE SPINE 143487, Catalog Number:PN15LSR15 81) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM1 82) KIT, LARGE SPINE 143487, Catalog Number:PN15LSRM2 83) KIT, LARGE SP

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code OJG·November 8, 2024

    Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number AGOH98Q; f) OPEN HEART ACCESSORY, kit number AGOH98R; g) OPEN HEART ACCESSORY, kit number AGOH98S; h) PERIPHERAL VASCULAR, kit number AGPV28O; i) PERIPHERAL VASCULAR, kit number AGPV28P; j) MINOR VASCULAR, kit number AHMV26J; k) MINOR VASCULAR, kit number AHMV26K; l) HEART PACK - 205947, kit number ANCV78AX; m) HEART PACK - 205947 , kit number ANCV78AX1; n) HEART PACK - 205947 Post Open-Heart, kit number ANHK74N; o) OPEN HEART EAST PACK, kit number BHOH43; p) 74OFF PUMP CABG PACK, kit number BHOP48; q) PACEMAKER PACK, kit number BHPM60; r) FORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K; s) T AND A PACK AGH ASC, kit number FBDI42L; t) T AND A PACK AGH ASC, kit number FBDI42M; u) THORACOSCOPY PACK, kit number FBTO60G; v) OPEN HEART ACCESSORY PACK, kit number JROH00O; w) OPEN HEART ACCESSORY PACK, kit number JROH98O; x) ADULT OPEN HEART PACK, kit number LLOH52; y) ADULT OPEN HEART PACK, kit number LLOP25; z) PACEMAKER PACK, kit number LLPP14; aa) HEART PACK, kit number LMCB06AD; bb) CARDIAC HEART BUNDLE NS, kit number LMCH99O; cc) OPEN HEAART PACK, kit number LMOH50AD; dd) OPEN HEAART PACK, kit number LMOH50AD-01; ee) OPEN HEAART PACK, kit number LMOH50AD-02; ff) OPEN HEAART PACK, kit number LMOH50AE; gg) CV PACK, kit number MMCV98V; hh) CV PACK, kit number MMCV98V-03; ii) CV PACK, kit number MMCV98V-04; jj) KIT OPEN HEART ADULT, kit number MMOH64J; kk) PACEMAKER PACK, kit number MMPM27E; ll) KIT, THORACOTOMY UNIVERSAL, kit number MMTR12F; mm) ANT CERV FUSION PACK, kit number NCAC96; nn) OPEN HEART- ACCESSOR, kit number NCOH11; oo) VASCULAR SAH, kit number SAVA91G; pp) VASCULAR SAH, kit number SAVA91H; qq) VASCULAR SAH, kit number SAVA91I; rr) VASCULAR SAH, kit number SAVA91J; ss) OPEN HEART BRINGBACK SJH, kit number SJOH17I; tt) OPEN HEART CV SJH, kit number SJOH28L; uu) PEDIATRIC HEART SJH, kit number SJPH34K; vv) VASC OPEN CVOR SJH, kit number SJVO56A; ww) VASC OPEN CVOR SJH, kit number SJVO56B; xx) MAJOR CV TRAY, kit number SVMJ20L; yy) MAJOR CV TRAY, kit number SVMJ20M; zz) MINOR CV TRAY, kit number SVMN60J; aaa) OPEN HEART COMPONENT PACK, kit number SVOH38Q; bbb) CV B PACK, kit number TNCB10AK; ccc) CARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code OEZ·November 29, 2023

    Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6) ROBOTIC CDS , Pack Number CDS981882Q ; 7) ROBOTIC CDS , Pack Number CDS981882R ; 8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ; 9) D&C CDS-WRMC, Pack Number CDS982331N ; 10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ; 11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ; 12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ; 13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ; 14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ; 15) GYN/ABDOMINAL , Pack Number CDS982725M ; 16) ROBOTIC CDS , Pack Number CDS982888D ; 17) ROBOTIC CDS , Pack Number CDS982888F ; 18) ROBOTIC CDS , Pack Number CDS982888G ; 19) ROBOTIC CDS , Pack Number CDS983028D ; 20) ZALE PUMP CDS , Pack Number CDS983187F ; 21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ; 22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ; 23) ROBOTIC CDS-LF, Pack Number CDS983258O ; 24) ROBOTIC CDS-LF, Pack Number CDS983258Q ; 25) VAGINAL MINOR , Pack Number CDS983268K ; 26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ; 27) ROBOTIC CDS , Pack Number CDS983399D ; 28) GYN VAGINAL CDS , Pack Number CDS983528L ; 29) GYN VAGINAL CDS , Pack Number CDS983528M ; 30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ; 31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ; 32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ; 33) OB CDS, Pack Number CDS983854B ; 34) OB/GYN CDS, Pack Number CDS984173F ; 35) GROTH VAGINAL , Pack Number CDS984201V ; 36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ; 37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ; 38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ; 39) GYN CDS , Pack Number CDS984860G ; 40) OB DELIVERY CDS , Pack Number CDS985027I ; 41) OB/GYN CDS RICE , Pack Number CDS985256C ; 42) OB/GYN CDS RICE , Pack Number CDS985256D ; 43) OB/GYN CDS RICE , Pack Number CDS985256F ; 44) OB CDS-LF , Pack Number CDS985320C ; 45) OB, Pack Number CDS985506D ; 46) OB, Pack Number CDS985506F ; 47) OB, Pack Number CDS985506G ; 48) OB, Pack Number CDS985506I ; 49) GYN LAPAROSCOPY , Pack Number CDS985519L ; 50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ; 51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ; 52) PERI-GYN PACK-LF, Pack Number DYNJ0038057; 53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ; 54) DAVINCI PACK-LF , Pack Number DYNJ0042750; 55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ; 56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ; 57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ; 58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ; 59) D AND C PACK-LF , Pack Number DYNJ0161028C ; 60) D AND C PACK-LF , Pack Number DYNJ0161028F ; 61) D AND C PACK-LF , Pack Number DYNJ0161028G ; 62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ; 63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ; 64) ROBOT PACK, Pack Number DYNJ01823F ; 65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ; 66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ; 67) OB PACK , Pack Number DYNJ03387A ; 68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ; 69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ; 70) OB PACK-LF, Pack Number DYNJ0367126L ; 71) OB PACK-LF, Pack Number DYNJ0367126M ; 72) OB PACK-LF, Pack Number DYNJ0367126N ; 73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ; 74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ; 75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ; 76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ; 77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ; 78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ; 79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ; 80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ; 81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ

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

    MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 2) BASIC BACK CDS, REF CDS780147N; 3) INSTRUMENTED BACK CDS, REF CDS780148R; 4) NEURO-LAMI CDS, REF CDS780208I; 5) TOTAL HIP, REF CDS920027Y; 6) TOTAL KNEE, REF CDS940072Y; 7) TOTAL KNEE REPLACEMENT CDS, REF CDS940823AB; 8) TOTAL HIP CDS, REF CDS940843AA; 9) TOTAL HIP CDS, REF CDS940963Y; 10) SHOULDER CDS, REF CDS941065L; 11) LAMINECTOMY CDS-LF, REF CDS981923X; 12) TOTAL KNEE CDS, REF CDS982823S; 13) LOWER EXTREMITY CDS, REF CDS982943S; 14) LOWER EXTREMITY CDS, REF CDS982943T; 15) TOTAL KNEE, REF CDS982986U; 16) EXTREMITY CDS, REF CDS983031Q; 17) PODIATRY CDS, REF CDS983610L; 18) TOTAL HIP CDS-LF, REF CDS983761N; 19) BASIC ORTHO CDS, REF CDS983769L; 20) UPPER EXTREMITY CDS, REF CDS983907L; 21) LOWER EXTREMITY CDS, REF CDS983909P; 22) GENERAL ORTHO CDS, REF CDS983915M; 23) MAJOR ORTHO, REF CDS984253L; 24) LOWER EXTREMTIY, REF CDS984254M; 25) TOTAL KNEE, REF CDS985566R; 26) ORTHO PACK, REF DYNJ00284M; 27) CRANIOTOMY PACK-LF, REF DYNJ0160354C; 28) CRANIOTOMY PACK-LF, REF DYNJ0161342C; 29) CRANIOTOMY PACK-LF, REF DYNJ0161342D; 30) CRANIOTOMY HARPER PACK-LF, REF DYNJ0162022G; 31) SPINE PACK-LF, REF DYNJ0376635P; 32) GP-TOTAL JOINT -LF, REF DYNJ0396868V; 33) GP-EXTREMITY/SHOULDER PACK-LF, REF DYNJ0396906P; 34) EXTREMITY PACK-LF, REF DYNJ0519273N; 35) TOTAL KNEE PACK-LF, REF DYNJ0530895AO; 36) TOTAL KNEE PACK-LF, REF DYNJ0530895AP; 37) UPPER EXTREMITY PACK-LF, REF DYNJ0532846S; 38) LOWER EXTREMITY PACK-LF, REF DYNJ0532852Q; 39) ACL SSC PACK-LF, REF DYNJ0536892U; 40) TOTAL HIP PACK-LF, REF DYNJ0536903AL; 41) TOTAL HIP PACK-LF, REF DYNJ0536903AM; 42) LOWER EXTREMITY PACK-LF, REF DYNJ0587115R; 43) TOTAL HIP PACK-LF, REF DYNJ0618354V; 44) TOTAL KNEE PACK-LF, REF DYNJ0646272S; 45) SPINE ANT POST ADD A PACK-LF, REF DYNJ0753208J; 46) OPEN SHOULDER SSC PACK, REF DYNJ0840659T; 47) TOTAL JOINT PACK-LF, REF DYNJ0885263F; 48) TOTAL KNEE PACK, REF DYNJ21813J; 49) CRANIO/MAXILOFACIAL #49-RF, REF DYNJ21826R; 50) TOTAL HIP PACK, REF DYNJ27315K; 51) PODIATRY PACK, REF DYNJ33978K; 52) LOWER EXTREMITY, REF DYNJ34420N; 53) LOWER EXTREMITY, REF DYNJ34420O; 54) GENERAL ORTHO, REF DYNJ34428O; 55) ARTHROSCOPY PACK, REF DYNJ35835G; 56) HAND PACK, REF DYNJ37697J; 57) ACH SPINE PACK, REF DYNJ38042K; 58) SHOULDER ARTHROSCOPY PACK, REF DYNJ38224C; 59) LAMINECTOMY PACK, REF DYNJ38227C; 60) EXTREMITY PACK, REF DYNJ38234G; 61) TOTAL JOINT PACK, REF DYNJ40982D; 62) SPINE PACK, REF DYNJ40995B; 63) EXTREMITY PACK, REF DYNJ41416G; 64) TOTAL JOINT PACK, REF DYNJ42793D; 65) CRANIOTOMY PACK-LF, REF DYNJ43208G; 66) HIP I PACK-LF, REF DYNJ43215I; 67) LAMINECTOMY PACK-LF, REF DYNJ43218G; 68) LIMB PACK-LF, REF DYNJ43220G; 69) SPLIT PACK-LF, REF DYNJ43225G; 70) TOTAL KNEE PACK-LF, REF DYNJ43226I; 71) EXTREMITY PACK, REF DYNJ44681J; 72) SHOULDER PACK, REF DYNJ44685L; 73) TOTAL KNEE PACK, REF DYNJ44687L; 74) UPPER EXTREMITY PACK, REF DYNJ44688I; 75) PODIATRY PACK, REF DYNJ44692G; 76) ACL PACK, REF DYNJ44849F; 77) CENTRACARE PLAZA-MINOR ORTHO, REF DYNJ44860I; 78) MAJOR EXTREMITY, REF DYNJ44878D; 79) ORTHO HIP, REF DYNJ44884G; 80) EXTREMITY PACK, REF DYNJ45332G;

    FDA Recall
    Open, Classified ·Product code OJH·September 30, 2025

    BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19 AUX3100S19 BLX3100S19 BRX3100S18 CAX3100S12 CAX3100T12 DEX3100S13 EEX3100S19 ESX3100S19 FRX3100S14 GBX3100H19 GBX3100S19 IAX3100S19 INX3100H19 INX3100S19 ITX3100S21 SPX3100S19 ; BiPAP A40 EFL, Part Numbers (OUS Only): AUX3000S19 DEX2900S13 DEX3000S13 EEX3000S19 ESX3000S19 FRX3000S14 GBX3000S19 INX3000H19 ITX3000S21

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code MNT·March 26, 2024