FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 57 of 520
Moderate Sep 18, 2024
25-LHP-928, HeNe Laser System, 25 mW
PACIFIC LASERTECH, LLC
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132701; 3) KI…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PR…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Siemens Healthcare Diagnostics, Inc.
Moderate Sep 18, 2024
N-LHP-928, HeNe Laser System, 35 mW
PACIFIC LASERTECH, LLC
Moderate Sep 18, 2024
Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Siemens Healthcare Diagnostics, Inc.
Moderate Sep 18, 2024
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12…
Ion Beam Applications S.A.
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILI…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J ; 2) UROLOGY MINOR CDS , Pack Number CDS980371K ; 3) CIRCUM…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095 ; 2) BREAST BIOPSY TRAY, Pack Number MNS5070; 3) BR…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BRE…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO PACK, Pack Number DYNJ42799
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam…
Hitachi America, Ltd., Particle Therapy Division
Moderate Sep 18, 2024
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) TRACHEOSTOMY, Pack Number DYNJ45495G ; 3) TRACH PACK, Pac…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3) CATHETER I…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Sy…
Sol-Millennium Medical Inc.
Moderate Sep 18, 2024
Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item N…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C; b) ANESTHESIA…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SO…
Sol-Millennium Medical Inc.
Moderate Sep 18, 2024
Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Product D…
Ultradent Products, Inc.
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
Smith & Nephew Inc.
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2) INSERTION TRAY, Pack Number CVI5080; 3) INCISION & DRAIN…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
Technomed Europe
Moderate Sep 18, 2024
Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No…
Sol-Millennium Medical Inc.
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355; b) ENDO BASIC KIT, Pa…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
CRANIOTOMY PACK, Pack Number DYNJ46552O
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Medtronic Perfusion Systems
Critical Sep 18, 2024
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Smiths Medical ASD Inc.
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X ; 2) ARTHROSCOPY TRAY, Pack Number AM110A ; 3) HIP…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063; 2) PULL D/C PACK, Pack Number DYNDA2080; 3) STERILE …
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C; b) GENERAL LAPAROSCO…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B; b) VIDEO BRONCHOSCOPY TRAY,…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) CHEST TUBE INSERTION TRAY, Pack Number CHT190…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D; b) ENT MIN…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS ,…
MEDLINE INDUSTRIES, LP - Northfield
Moderate Sep 18, 2024
Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY,…
MEDLINE INDUSTRIES, LP - Northfield
Critical Sep 18, 2024
smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ; 2) BL…
Smiths Medical ASD Inc.
Moderate Sep 18, 2024
Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K
MEDLINE INDUSTRIES, LP - Northfield
Critical Sep 18, 2024
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Percutaneo…
Smiths Medical ASD Inc.
Moderate Sep 18, 2024
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Siemens Healthcare Diagnostics, Inc.
Moderate Sep 18, 2024
Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
MEDLINE INDUSTRIES, LP - Northfield