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    Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures.

    FDA Recall
    Terminated ·Berchtold Corp.·Product code FWH·July 10, 2012

    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW

    FDA Recall
    Terminated ·GN Hearing A/S Lautrupbjerg 7 Ballerup Denmark·Product code ESD·September 18, 2019

    DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

    FDA Recall
    Open, Classified ·Katalyst Surgical, LLC·Product code HNR·March 25, 2026

    DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

    FDA Recall
    Open, Classified ·Katalyst Surgical, LLC·Product code HNR·March 25, 2026

    25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.

    FDA Recall
    Terminated ·Synergetics Inc·Product code HQB·December 9, 2013

    Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS; 7) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS; 8) CUSTOM KIT, REF DYNDA2060; 9) CHEST TRAY PACK, REF DYNDA2203; 10) PK LESION CSTM, REF DYNDA2914; 11) BRONCH ESOPHAGOSCOPY PACK, REF DYNDH1765; 12) SOFT TISSUE PACK, REF DYNJ00017M; 13) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 14) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 15) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I; 16) MINOR PACK-LF, REF DYNJ0410060S; 17) CYSTO I TRAY, REF DYNJ14063D; 18) CYSTO I TRAY, REF DYNJ14063D; 19) CYSTO PACK, REF DYNJ17310D; 20) DENTAL PK-LF, REF DYNJ21241D; 21) CYSTO PACK-LF, REF DYNJ25042I; 22) BASIC PACK-LF, REF DYNJ25450I; 23) BASIC PACK-LF, REF DYNJ25450J; 24) OPS T&A PACK, REF DYNJ26876F; 25) BASIC PACK, REF DYNJ31835G; 26) DENTAL PACK, REF DYNJ32991C; 27) MEDVET PROCEDURE PACK, REF DYNJ34226C; 28) MEDVET PROCEDURE PACK, REF DYNJ34226C; 29) CYSTO, REF DYNJ34527B; 30) UNIVERSAL PACK, REF DYNJ35593D; 31) T&A PACK, REF DYNJ36434A; 32) ENSEMBLE PROCEDURE MINEURE-LF, REF DYNJ38085C; 33) TYMPANOMASTOID PACK, REF DYNJ39342C; 34) OB DELIVERY PACK, REF DYNJ39377C; 35) PK,ENT-T&A, REF DYNJ39548A; 36) PACEMAKER SET UP PACK-LF, REF DYNJ40010B; 37) GENERAL OVERBED PACK, REF DYNJ40045B; 38) GENERAL OVERBED PACK, REF DYNJ40045B; 39) MAJOR OPHTHALMIC, REF DYNJ40317; 40) ENSEMBLE ACCOUCHEMENT-LF, REF DYNJ40933A; 41) ORL TYMPANO PACK BJC-LF, REF DYNJ41674A; 42) TURP PACK BWH-LF, REF DYNJ41706C; 43) TURP PACK BWH-LF, REF DYNJ41706C; 44) CYSTOSCOPY PACK BWH-LF, REF DYNJ41709B; 45) ORAL SURGERY PACK WRO-LF, REF DYNJ41862C; 46) MAJOR CYSTO PACK WRO-LF, REF DYNJ41871B; 47) BASIC SET UP TRAY-LF, REF DYNJ42142A; 48) CHEST TUBE, REF DYNJ42491; 49) BASIC PACK-LF, REF DYNJ43400C; 50) ENT PACK, REF DYNJ43538B; 51) MGASC MINOR PK-22025183, REF DYNJ44818D; 52) GEN SURG - MINOR-LF, REF DYNJ45731A; 53) STERILE FIELD, REF DYNJ46227B; 54) STERILE FIELD, REF DYNJ46227B; 55) BASIC PACK, REF DYNJ47823C; 56) MINOR PACK, REF DYNJ49825C; 57) CYSTO PACK, REF DYNJ50073B; 58) CYSTO PACK, REF DYNJ50073B; 59) 7497 VAT SURGICAL KIT, REF DYNJ50320B; 60) ENSEMBLE CYSTOSCOPIE-LF, REF DYNJ50946A; 61) ENT PACK, REF DYNJ51360; 62) PK-GEN-BASIC, REF DYNJ52220A; 63) MINOR PACK, REF DYNJ52782C; 64) LEG ROLL KIT, REF DYNJ53020; 65) CYSTO PACK-LF, REF DYNJ53204A; 66) TREATMENT ROOM TRAY-LF, REF DYNJ53268; 67) BASIC SET UP PK, REF DYNJ53509B; 68) T AND A PACK, REF DYNJ54087A; 69) TUR PACK, REF DYNJ54483A; 70) FTMC LOCAL PACK-LF, REF DYNJ54607B; 71) TONSIL PACK, REF DYNJ54765C; 72) SPINAL CORD STIMULATION, REF DYNJ57294; 73) T&A PACK, REF DYNJ57810; 74) PROCEDURE PACK, REF DYNJ58538; 75) ENSEMBLE MAIN/POIGNET, REF DYNJ59375; 76) MINOR PACK, REF DYNJ59621A; 77) CYSTO, REF DYNJ60307A; 78) MEDVET PROCEDURE PACK, REF DYNJ60368B; 79) DR. HUNT PACK, REF DYNJ61218; 80) CYSTO PACK, REF DYNJ61506A; 81) SLCH DIGITAL XRAY PACK, REF DYNJ61664A; 82) MHPB CONVERSION PACK, REF DYNJ62027A; 83) SMALL PROCEDURE PACK, REF DYNJ62231; 84) DENTAL PACK, REF DYNJ62619A; 85) BASIC PACK-LF, REF DYNJ63522A; 86) BASIC PACK, REF DYNJ64865; 87) INFERTILITY PACK, REF DYNJ65720; 88) SETUP PACK, REF DYNJ67675A; 89) TLPO PACK, REF DYNJ68312; 90) SURGERY PACK, REF DYNJ68458; 91) KF PACK 2.0, REF DYNJ69619; 92) SURGERY PACK, REF DYNJ69692; 93) DR GREEN PACK, REF DYNJ80043; 94) DRAPE PACK II, REF DYNJ80154B; 95) UNIVERSAL PACK, REF DYNJ80178A; 96) GENERAL SURGERY PACK, REF DYNJ80194; 97) SUPPLEMENT MIPS PK, REF DYNJ80244C; 98) UNIVERSAL PACK, REF DYNJ80401A; 99) UNIVERSAL PACK, REF DYNJ80401A; 100) LITHOTOMY PACK, REF DYNJ80765; 101) PKY LITHOTOMY PACK, REF DYNJ81656A; 102) SOFT TISSUE PACK, REF DYNJ82029; 103) MAJOR SURGI

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

    Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CDS-LF b. ROBOTIC CDS c. GYN LAPAROSCOPY CDS-LF d. GYN LAPAROSCOPY e. GYN LAPAROSCOPY CDS f. UNIVERSAL ROBOTIC ORLANDO g. GYN ROBOTIC CDS h. GYN LAPAROSCOPY CDS-1 i. CUH GYN LAPAROSCOPY CDS j. CUH GEN/GYN ROBOTIC CDS k. LAVH CDS-LF l. GYN LAPAROSCOPY CDS-LF m. GYN LAPAROSCOPY CDS UCC-LF n. DAY SURG GYN LAP CDS o. GYN LAPAROSCOPY CDS p. DAVINCI HYSTERECTOMY CDS q. GYN LAP/ROBOTIC r. DAVINCI PACK-LF s. DAVINCI PACK-LF t. GYN LAPAROSCOPY PACK-LF u. ROBOTIC PACK v. GYN LAP - UNIV w. BASIC LAVH PACK x. GYN/LAPAROSCOPY PACK-LF y. LAPAROSCOPIC GYN PACK-LF z. DAVINCI PACK-LF aa. SCC GYN LAPAROSCOPY PACK bb. URO GYN PACK-LF cc. GYN LAPAROSCOPY PACK dd. TUBAL PACK ee. GYN LAP PACK-LF ff. LAVH PACK gg. GYN LAPAROSCOPY-LF hh. LAVH PACK ii. PK-GYN-LAPAROSCOPY jj. MAJOR LAP PACK 2-LF kk. TUBAL PACK ll. GYN LAPAROSCOPY PACK-LF mm. PK, ROBOTICS-GYN nn. SVMMC GEN ROBOTIC PACK oo. SVMMC GYN ROBOTIC PACK pp. PACK, GYN-D&C qq. DA VINCI PROSTATE/COLPOPEXY rr. ROBOT PACK ss. PK, GYN-LAPAROSCOPY tt. LAPAROSCOPIC GYN PACK uu. DAVINCI PACK-RFD vv. GYN ROBOTIC PACK ww. LAVH PACK xx. ST. ANNE'S MULTI PORT PACK yy. LAVH PACK zz. SOUTH SC RFT GYN LAP PACK aaa. GYN LAPAROSCOPY PACK bbb. LITHOTOMY PENILE PACK ccc. DAVINCI GENERAL PACK ddd. DAVINCI GYN PACK eee. DAVINCI GYN PACK fff. ROBOTIC PROSTATE PACK ggg. GYN ROBOTIC PACK-LF hhh. SCRIPPS SW ROBOTIC PACK iii. GYN LITHOTOMY PACK jjj. GYN LAPAROSCOPY PACK kkk. DEACONESS PELVIC LAP PACK lll. WOMENS ROBOT PACK mmm. GYN LAPAROSCOPY PACK-LF nnn. MAJOR GYN PACK ooo. GYN LAPAROSCOPY PACK ppp. TUBAL PACK-LF qqq. PK, GYN-LAPAROSCOPY rrr. LAVH PACK sss. LAPAROTOMY PACK ttt. URO/GEN ROBOTIC PACK uuu. BASIC ROBOTIC PACK vvv. LAPAROSCOPIC GYN PACK www. PK, ROBOTICS-GYN xxx. PQ CHG CTRY GYN LAP PK yyy. GYN DAVINCI PACK zzz. ROBOT GYN SHARED aaaa. PK, ROBOTICS-GEN bbbb. DAVINCI PACK cccc. ROBOTIC GYN PACK dddd. ROBOTICS PACK eeee. PK- ROBOTICS ffff. GYN LAPAROSCOPY gggg. GU ROBOTIC PACK hhhh. GYN PACK iiii. BASIC GYN PACK jjjj. BWH GYN ROBOTICS PACK kkkk. BWH GU ROBOTICS PACK llll. URO GYN PACK mmmm. GYN LAP PACK nnnn. GYN LAPAROSCOPY oooo. ROBOTIC pppp. GYN ROBOTIC qqqq. CV ROBOTIC SET UP rrrr. GYN LAPAROSCOPY ssss. ROBOTIC LAVH tttt. ROBOTIC LAP CHOLE uuuu. GYN LAPAROSCOPY vvvv. GYN LAPAROSCOPY wwww. GYN ROBOTIC xxxx. GYN ENDOSCOPY-LF yyyy. GYN LAPAROSCOPY zzzz. LAP ROBOTIC aaaaa. TUBAL LIGATION CDS bbbbb. GYN LAPAROSCOPY ccccc. ROBOTIC GYN & GU ddddd. ROBOTIC eeeee. GYN LAPAROSCOPY fffff. ROBOT GYN ggggg. GYN LAPAROSCOPY hhhhh. FHWC ROBOTIC iiiii. GYN LAPAROSCOPY jjjjj. GYN LAPAROSCOPY kkkkk. ROBOTIC lllll. PELVISCOPY mmmmm. GENERAL ROBOT-TCN nnnnn. ROBOTICS ooooo. CVOR ROBOT ppppp. GU-GEN ROBOTIC qqqqq. FLOYD LAP GYN rrrrr. GYN ROBOTIC sssss. GYN LAPAROSCOPY CDS ttttt. LAP TUBAL uuuuu. DAVINCI GENERAL vvvvv. DAVINCI LOW ANTERIOR RESECTION wwwww. GYN xxxxx. PELVISCOPY PACK yyyyy. GYN LAPAROSCOPY STD PACK-LF zzzzz. LAP GYN PACK-LF

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

    Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY, REF SUT19510; g) LACERATION TRAY, REF SUT8565; h) LACERATION TRAY, REF SUT8565; i) LINE REPAIR KIT, REF MNS12045A; j) MMC DAILY DRIVELINE MGMT KIT, REF DM850A; k) NEWBORN THORACOTOMY TRAY, REF MNS3470; l) NICU STERILE CENTRAL LINE CHANGE KIT, REF DT18520A; m) OMMAYA KITS - LATEX FREE, REF HT2375; n) PEDIATRIC ULTRASOUND KIT, REF MNS12995A; o) PORT ACCESS INFUSION KIT - 1IN NEEDLE, REF DYNDC2817C; p) WOUND CLOSURE AND IRRIGATION TRAY, REF SUT14785;

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

    Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640; c) DAILY DRIVELINE MGMT SYSTEM, REF DM600; d) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; e) DAILY MAINTENANCE SYSTEM LVAD, REF DM870A; f) DRESSING CHANGE TRAY WITHOUT DRESSING, REF DT21465B; g) DRIVELINE MANAGEMENT SYSTEM, REF DT18905; h) DRIVELINE MANAGEMENT SYSTEM-DAILY, REF DM610; i) DRIVELINE MGMT TRAY W/O ANCHOR, REF DT18210; j) DRIVELINE MGMT. KIT WITH SILVER ALGINATE, REF DT18695A; k) LVAD DAILY PATIENT CHANGE KIT, REF DM630; l) LVAD DAILY PATIENT CHANGE KIT, REF DM630; m) LVAD DRIVELINE MGMT KIT, SENSITIVE SKIN, REF DT19005A; n) LVAD MAINTENANCE KIT - LESS THAN 6 MOS., REF DM1060; o) LVAD SENSITIVE KIT, REF DM525A; p) MMC DAILY DRIVELINE MGMT KIT, REF DM850; q) PATIENT DRESSING CHANGE KIT SW, REF DT17355; r) PEDIATRIC PORT ACCESS BUNDLE, REF DT19835B; s) PORT ACCESS KIT, REF DT22575A; t) PORT ACCESS TRAY, REF DT20845B; u) PORT DRESSING CHANGE TRAY, REF DT20885B; v) PORT DRESSING CHANGE KIT, REF DT21585B; w) PORT DRESSING CHANGE KIT, REF DYNDC2815A; x) PORT KIT, REF DT22270A; y) UOU LVAD DRIVELINE MGMT COMPLICATIONS, REF DM330A; z) UOU LVAD DRIVELINE MGMT COMPLICATIONS, REF DM330A; aa) VAD DRESSING CHANGE TRAY, REF DM875; bb) VAD DRESSING CHANGE TRAY, REF DM875; cc) VAD DRIVELINE MANAGEMENT KIT HW, REF DM1105

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

    Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWH·November 17, 2011

    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

    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