12 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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
EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Recall
Open, Classified
·MHC Medical Products LLC·Product code FMI·April 6, 2018
EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
FDA Recall
Open, Classified
·MHC Medical Products LLC·Product code FMI·April 6, 2018
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
Basic Biopsy Tray, Item Number NMBP44L
FDA Recall
Open, Classified
·American Contract Systems Inc.·Product code FCH·September 4, 2025
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
Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A; 6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A; 7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH; 8) PACK,BREAST BIOPSY, Pack Number DYNDL1498; 9) BONE MARROW PACK, Pack Number DYNJ0628436I ; 10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K; 11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH; 12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ; 13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH; 14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ; 15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ; 16) BIOPSY TRAY , Pack Number DYNJ31585C ; 17) BONE MARROW KIT PK, Pack Number DYNJ37526; 18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ; 19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ; 20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ; 21) BIOPSY TRAY , Pack Number DYNJ49368; 22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ; 23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550; 24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ; 25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D; 26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B; 27) PACK,FETOSCOPY, Pack Number DYNJ906905B; 28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035; 29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ; 30) BIOPSY TRAY , Pack Number SPEC0150 ; 31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B; 32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·April 8, 2024
Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY-LF b. BREAST BIOPSY-LF
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·November 17, 2022
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FETOSCOPY CDS-LF, Model Number: CDS840215O; c. PACK,FETOSCOPY, Model Number: DYNJ906905A; d. US BREAST BIOPSY TRAY, Model Number: DYNDH1187A;
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code FCH·May 15, 2023
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
FDA Recall
Open, Classified
·American Contract Systems, Inc.·Product code FCH·November 29, 2023
American Contract Systems Biopsy Drape Pack convenience kit
FDA Recall
Open, Classified
·American Contract Systems, Inc.·Product code FCH·May 6, 2024