30 results
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15ms
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Sources: EU EUDAMED, US FDA
Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 5) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B; 6) PHLEBECTOMY PACK, Model Number: DYNJ55215G; 7) BIOPSY/DRAINAGE TRAY-LF, Model Number: DYNJ30078D; 8) CAT BIOPSY PACK, Model Number: DYNJ62968; 9) ABLATION/DRAINAGE PACK, Model Number: DYNJ53658D; 10) BIOPSY KIT, Model Number: DYNJ61130B
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OFG·March 3, 2025
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Recall
Open, Classified
·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.
FDA Recall
Open, Classified
·TECHNO-PATH MANUFACTURING LTD. Fort Henry Business Park Ballina Tipperary Ireland·Product code OHQ·October 17, 2025
Design Options Spinal Tray Material Description (Material Number): SSK HACKENSACK MEDICAL CTR 20061890 (560074), SSK SUTTER COMMUNITY HOSPITAL (560214), SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272), SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327), SSK TORRANCE MEMORIAL HOSPITAL (560394), SSK SURGERY ONE 20070208 (560428), SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462), SSK HOAG MEMORIAL HOSPITAL (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK KAISER FOUNDATION HOSPITAL (560497), SSK THOMAS JEFFERSON UNIV HOSP (560513), SSK OVERLAKE MEDICAL CENTER (560521), SSK CUSTOM SPINAL TRAY (560523), SSK ORLANDO REGIONAL MED CENTER (560533), SSK BON SECOURS HEALTH SYS 20115122 (560538), SSK MANATEE MEMORIAL (560572), SSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580), SSK SHANDS TEACHING HOSP. & CLINICS, INC (560584), SSK UNIVERSITY OF COLORADO (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK MAYO CLINIC - BUPIVACAINE TRAY (560609), SSK THE MEDICAL CENTER (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK MAYO CLINIC OB DEPT - SPINAL (560645), SSK BAPTIST HOSPITAL OF MIAMI (560646), SSK MERCY GILBERT MEDICAL CENTER (560647), SSK ST.MARY'S HOSPITAL (560648), SSK HARRIS HEALTH SYSTEM (560660), OHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667), ALBANY MEDICAL CENTER, SSK (560670), STONY BROOK HOSPITAL - SPINAL TRAY SSK (560672);
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code OFU·May 6, 2026
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE LITHOMIE MINEURE-LF, Model Number: DYNJ47552C; 6) CH D&C PACK, Model Number: DYNJ67945; 7) LAP GYN PACK-LF, Model Number: DYNJ25892K; 8) GYN LAPAROSCOPY PACK BJC-LF, Model Number: DYNJ41670B; 9) OPP GYN VAGINAL PACK, Model Number: DYNJ67227; 10) GYNE MINOR LAPAROSCOPY GRH-LF, Model Number: DYNJ41790F; 11) GYNE - LITHOTOMY MINOR PACK-LF, Model Number: DYNJ49251C; 12) STANDARD D&C, Model Number: DYNJ69733; 13) PERI GYN PACK, Model Number: DYNJ24338I; 14) GYN LAPAROSCOPY CDS, Model Number: CDS982727L; 15) ROBOTICS, Model Number: DYNJ908712B
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OHD·March 3, 2025
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ82437A; 5) C LINE INSERTION CDS, Model Number: CDS980379J; 6) BSHR PICC LINE-LF, Model Number: DYNJ24529M; 7) ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; 8) PICC LINE PACK, Model Number: DYNJ55170F; 9) LINE INSERTION PACK, Model Number: DYNJ44949C; 10) RFA PACK, Model Number: DYNJ67899A; 11) KIT CENTRAL LINE INSERTION-LF, Model Number: PHS902533005; 12) INFANT LUMBAR PUNCTURE TRAY, Model Number: DYNDH1904; 13) PICC PACK-LF, Model Number: DYNJ55356A; 14) GENERAL TRAY, Model Number: DYNJ15652M; 15) CVR ENDOVENOUS PACK, Model Number: DYNJ80643; 16) LINE INSERTION TRAY, Model Number: DYNJ20803D
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OFF·March 3, 2025
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code LNZ·February 12, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code CAE·November 6, 2023
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code CAE·November 6, 2023
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
FDA Recall
Open, Classified
·Sarnova HC, Llc·Product code LNZ·February 12, 2024
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-LF, Model Number: DYNJ55343B; 6) CARDIAC PACK, Model Number: DYNJ65027B; 7) VASCULAR PACK-LF, Model Number: DYNJ48196C; 8) IMPLANT PACK, Model Number: DYNJ40480; 9) OPEN HEART, Model Number: DYNJ900523B; 10) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 11) CHOG VP SHUNT PACK, Model Number: SYNJ10280C; 12) VASCULAR PACK-LF, Model Number: DYNJ48196C; 13) EP PACK-LF, Model Number: DYNJ27949F; 14) PACEMAKER PACK WRO-LF, Model Number: DYNJ41874C; 15) CARDIAC PACK OPTION 1, Model Number: DYNJ83208A; 16) EP DRAPE PACK, Model Number: DYNJ56729; 17) CSTM EP PACEMAKER DRAPE PACK, Model Number: DYNJCD0326; 18) MINOR INTERVENTIONAL TRAY, Model Number: DYNJ80084; 19) CT PACK, Model Number: DYNJ39111A; 20) VASCULAR PACK-LF, Model Number: DYNJ25102I; 21) VASCULAR ACCESS PROCEDURE PACK, Model Number: DYNJ62339; 22) ANGIO TRAY, Model Number: DYNJ43278C; 23) PACEMAKER PACK-LF, Model Number: DYNJ19758I; 24) E.P. BASIC PACK-LF, Model Number: DYNJ24735F; 25) PORT A CATH PACEMAKER BJC-LF, Model Number: DYNJ41683B; 26) PACEMAKER PACK, Model Number: DYNJ39379C; 27) VEIN PACK, Model Number: DYNJ64016B; 28) EP PACK, Model Number: DYNJ68019A; 29) ENDOVENOUS BASIC PACK, Model Number: DYNJ69108A; 30) PACEMAKER PACK-LF, Model Number: DYNJHTCLP101A; 31) EP PACK, Model Number: DYNJ38147C; 32) HEART PRCMNT CHOICE, Model Number: DYNDA1841; 33) PACEMAKER PACK SMGH-LF, Model Number: DYNJ41925I; 34) EP PACK, Model Number: DYNJ81951B; 35) HEALTH ALL VASCULAR PACK-LF, Model Number: DYNJ19538F; 36) OPEN HEART, Model Number: CDS982026V; 37) OPEN HEART, Model Number: CDS982026V
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·March 3, 2025
Tenaculum, Plastic
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
IUD Insertion Pack
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
Foundation Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
FDA Recall
Open, Classified
·The Anspach Effort, Inc.·Product code HBC·December 7, 2022
Standard IUD Insertion Kit
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
FDA Recall
Open, Classified
·The Anspach Effort, Inc.·Product code HBC·December 7, 2022
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
FDA Recall
Open, Classified
·The Anspach Effort, Inc.·Product code HBC·December 7, 2022
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
FDA Recall
Open, Classified
·The Anspach Effort, Inc.·Product code HBC·December 7, 2022
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
FDA Recall
Open, Classified
·The Anspach Effort, Inc.·Product code HBC·December 7, 2022