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    Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code OWB·November 24, 2021

    Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722029, 722033, 722034, 722036, 722038, 722039. Allura Xper F010 {C+F). 722003 Allura Xper F010/10 722005 Allura Xper F020 722006 Allura Xper F020/10 and F020/20 722008 Allura Xper F010 722010 Altura Xper F010/10 722011 Allura Xper F020 722012 Allura Xper FD20 biplane 722013 Allura Xper FDlO OR Table 722014 Allura Xper FD20 OR Table 722015 Allura Xper FDl0/10 OR Table 722019 Allura Xper FD20 Biplane OR Table 722020 Allura Xper FD10 OR Table 722022 Allura Xper FD20 OR Table 722023 Allura Xper FD10/10 OR Table 722024 Altura Xper FD20 Biplane OR Table 722025 Allura Xper FD10 722026 Allura Xper FD10/10 722027 Altura Xper FD20/10 biplane 722029 Allura Xper FD10 OR Table 722033 Allura Xper FD10/10 OR Table 722034 Allura Xper FD20/10 OR Table 722036 Allure Xper F020/20 722038 Altura Xper FD20/20 biplane OR Table 722039

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code OWB·November 24, 2021

    Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·May 23, 2025

    Medtronic Grafton Plus Paste a) DBM S45001 GRAFTON 1CC PASTE, REF S45001; b) DBM S45005 GRAFTON 5CC PASTE, REF S45005; c) DBM S45010 GRAFTON 10CC PASTE, REF S45010; d) DBM T45001 1CC PASTE GRAFTON PLUS, REF T45001; e) DBM T45001AUS 1CC PASTE GRAFTON PLUS, REF T45001AUS; f) DBM T45001INT 1CC PASTE GRAFTON PLUS, REF T45001INT; g) DBM T45005 5CC PASTE GRAFTON PLUS, REF T45005; h) DBM T45005INT 5CC PASTE GRAFTON PLUS, REF T45005INT; i) DBM T45010 10CC PASTE GRAFTON PLUS, REF T45010; j) DBM T45010AUS 10CC PASTE GRAFTON PLUS, REF T45010AUS; k) DBM T45010INT 10CC PASTE GRAFTON PLUS, REF T45010INT; Demineralized Bone Matrix (DBM) product

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023

    Medtronic Grafton Putty: a) DBM S43101 GRAFTON 0.5CC PUTTY, REF S43101; b) DBM S43102 GRAFTON 1CC PUTTY, REF S43102; c) DBM S43103 GRAFTON 2.5CC PUTTY, REF S43103; d) DBM S43105 GRAFTON 5CC PUTTY, REF S43105; e) DBM S43110 GRAFTON 10CC PUTTY, REF S43110; f) DBM T43101 0.5CC GRAFTON PUTTY, REF T43101; g) DBM T43101INT 0.5CC GRAFTON PUTTY, REF T43101INT; h) DBM T43102 1CC GRAFTON PUTTY, REF T43102; i) DBM T43102INT 1CC GRAFTON PUTTY, REF T43102INT; j) DBM T43102JPN GRAFTON PUTTY 1CC JAR, REF T43102JPN; k) DBM T43103 2.5CC GRAFTON PUTTY, REF T43103; l) DBM T43103INT 2.5CC GRAFTON PUTTY, REF T43103INT; m) DBM T43103JPN GRAFTON PUTTY 2.5CC JAR, REF T43103JPN; n) DBM T43105 5CC GRAFTON PUTTY, REF T43105; o) DBM T43105INT 5CC GRAFTON PUTTY, REF T43105INT; p) DBM T43105JPN GRAFTON PUTTY 5CC JAR, REF T43105JPN; q) DBM T43110 10CC GRAFTON PUTTY, REF T43110; r) DBM T43110INT 10CC GRAFTON PUTTY, REF T43110INT; Demineralized Bone Matrix (DBM) product

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023

    Medtronic Grafton Gel: a) DBM S41120 GRAFTON GEL 1CC, REF S41120; b) DBM S41150 GRAFTON GEL 10CC, REF S41150; c) DBM T41110 0.5CC GRAFTON GEL, REF T41110; d) DBM T41110INT 0.5CC GRAFTON GEL, REF T41110INT; e) DBM T41120 1CC GRAFTON GEL, REF T41120; f) DBM T41120INT 1CC GRAFTON GEL, REF T41120INT; g) DBM T41130 5CC GRAFTON GEL, REF T41130; h) DBM T41130INT 5CC GRAFTON GEL, REF T41130INT; i) DBM T41150 10CC GRAFTON GEL, REF T41150; j) DBM T41150INT 10CC GRAFTON GEL, REF T41150INT; Demineralized Bone Matrix (DBM) product

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023

    Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023

    microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.

    FDA Recall
    Open, Classified ·FHC, Inc.·Product code HAW·October 4, 2024

    Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRCUMCISION TRAY, Pack Number CIT6860A; 4) CIRCUMCISION TRAY, Pack Number CIT6715; 5) CIRCUMCISION TRAY, Pack Number DYNDA2271; 6) CIRCUMCISION TRAY, Pack Number CIT7020; 7) CIRCUMCISION TRAY, Pack Number CIT7210; 8) CIRCUMCISION TRAY, Pack Number CIT6720A; 9) CIRCUMCISION TRAY, Pack Number CIT6665; 10) CIRCUMCISION TRAY , Pack Number CIT6050 ; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) CIRCUMCISION TRAY WITHOUT CLAM, Pack Number CIT6255 ; 13) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 14) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 15) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 16) NICU PROCEDURE TRAY , Pack Number UVT925 ; 17) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 18) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 19) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 20) SHAVE KIT, Pack Number MNS8250; 21) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497; 22) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496; 23) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512A; 24) UMBILICAL VES CATH INSERT TRAY, Pack Number UVT3594 ; 25) UMBILICAL VESSEL TRAY W/O CATH, Pack Number UVT170 ; 26) UMBILICAL VESSEL TRAY W/OUT CA, Pack Number UVT475

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

    DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100

    FDA Recall
    Open, Classified ·Musculoskeletal Transplant Foundation, Inc.·Product code MQV·September 22, 2023

    Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERILE 1CC SYR W/ 25GX5/8 NDL, Pack Number DYNDA2497

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

    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7020; 6) CIRCUMCISION TRAY, Pack Name DYNDA2271; 7) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Name CIT6920; 8) NURSERY CIRCUMCISION TRAY, Pack Name CIT4845; 9) PUNCH BIOPSY KIT, Pack Name MNS8245; 10) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Name DYNDA2496

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

    Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM, Pack Number DYNDH1446A; 2) ARTHROGRAM TRAY, Pack Number MNS11965A; 3) ARTHROGRAPH TRAY, Pack Number MNS12670A; 4) BREAST BIOPSY KIT, Pack Number DYNDH1512; 5) CIRCUMCISION KIT, Pack Number CIT6535; 6) CIRCUMCISION KIT, Pack Number CIT7095; 7) CIRCUMCISION TRAY, Pack Number CIT7020; 8) CIRCUMCISION TRAY, Pack Number CIT6720; 9) CIRCUMCISION TRAY, Pack Number CIT6715; 10) CIRCUMCISION TRAY, Pack Number CIT7210; 11) CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6925; 12) DISPOSABLE NICU UMBILICAL INSERTION TRAY, Pack Number UVT1030; 13) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 14) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 15) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 16) PUNCH BIOPSY KIT, Pack Number MNS8245; 17) RETINAL INJECTION KIT, Pack Number MNS12465; 18) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Number DYNDA2496

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

    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FCG·March 31, 2023

    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

    FDA Recall
    Open, Classified ·Custom Medical Specialties, Inc.·Product code FCH·September 20, 2016

    Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code FCG·June 26, 2020

    Basic Biopsy Tray, Item Number NMBP44L

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

    Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code FCG·June 26, 2020

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETOSCOPY CDS-LF, Model Number CDS840215O; b) US BREAST BIOPSY TRAY, Model Number DYNDH1187A; c) PACK,FETOSCOPY, Model Number DYNJ906905B

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

    Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·December 27, 2022