FDA Device · 2024

FDA Device recalls in 2024

RecallRadar indexes 3,393 FDA Device recall notices published in 2024. By classification: 392 Class I, 2,970 Class II, 31 Class III.

• smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs P…
  FDA Device · Class I · 2024-09-18 · Smiths Medical Asd
• Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits, labeled as: 1) NERVE BLOCK TRAY-LF, Pack Number DYNJRA0377B
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) CHEST TUBE INSERTION TRAY, Pack Number DYNDA2063
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits, labeled as: 1) BLOOD CULTURE COLLECTION KIT, Pack Number BP115
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis…
  FDA Device · Class II · 2024-09-18 · Fresenius Medical Care Holdings
• Medline Convenience kits labeled as: HSG TRAY, Pack Number DYNDH1453
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
  FDA Device · Class I · 2024-09-18 · Smiths Medical Asd
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO BRONCH PACK, Pack Number DYKE1355
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A
  FDA Device · Class II · 2024-09-18 · Sol Millennium Medical
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB VITRECTOMY, Pack Number DYNJ59921B
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human se…
  FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics
• Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) SPECIAL PROCEDURE PACK ARTERI , Pack Number 00-399024X
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
  FDA Device · Class II · 2024-09-18 · Medtronic Xomed
• Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proto…
  FDA Device · Class II · 2024-09-18 · Hitachi America Particle Therapy Division
• Medline Convenience kits, labeled as: 1) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS983874F
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ANESTHESIA CIRCUIT-LF, Pack Number DYNJAA0311C
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
  FDA Device · Class I · 2024-09-18 · B Braun Medical
• Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• 25-LHP-828, HeNe Laser System, 35 mW
  FDA Device · Class II · 2024-09-18 · Pacific Lasertech
• Pneupac paraPAC plus 300 ventilator kit, REF P300NXX
  FDA Device · Class I · 2024-09-18 · Smiths Medical Asd
• 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
  FDA Device · Class II · 2024-09-18 · Sol Millennium Medical
• Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) BAPTIST FLOYD BRONCHOSCOPY, Pack Number DYKE1456D
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309I
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequenc…
  FDA Device · Class II · 2024-09-18 · Olympus
• Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit…
  FDA Device · Class II · 2024-09-18 · Ultradent Products
• Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number DYNJ0621408V
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) OFFICE PACK FOR HYSTEROSCOPY, Pack Number C040100
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits, labeled as: 1) SINGLE SHOT EPIDURAL PACK-LF, Pack Number DYNJ0708470K
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits, containing Shenli syringes, labeled as: 1) LOCAL PACK, Pack Number DYNJ34129C
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Descriptio…
  FDA Device · Class II · 2024-09-18 · Ultradent Products
• Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551
  FDA Device · Class II · 2024-09-18 · Sol Millennium Medical
• Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human se…
  FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics
• Medline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT NEURO SHUNT ST LOUIS CHILD, Pack Number DYNJ907829B
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1092B
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
  FDA Device · Class II · 2024-09-18 · Zoe Medical
• Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP)
  FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics
• Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Cathe…
  FDA Device · Class II · 2024-09-18 · Bard Peripheral Vascular
• Medline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• N-LHP-928, HeNe Laser System, 35 mW
  FDA Device · Class II · 2024-09-18 · Pacific Lasertech
• Medline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number CVI4915
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 ea…
  FDA Device · Class II · 2024-09-18 · Medical Action Industries 306
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• CRANIOTOMY PACK, Pack Number DYNJ46552O
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number BT1095
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and…
  FDA Device · Class II · 2024-09-18 · Medtronic Neuromodulation
• Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number DYNJSYR12CP
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/060CZ
  FDA Device · Class I · 2024-09-18 · Smiths Medical Asd
• Medline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427C
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits, labeled as: SPINAL BLOCK 22G QUINCKE 5S BU, Pack Number DYNJRA9026
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number DYKMBNDL37AH
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W
  FDA Device · Class II · 2024-09-18 · Biofire Diagnostics
• Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, Pack Number 59112
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
  FDA Device · Class II · 2024-09-18 · Medtronic Perfusion Systems
• Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human s…
  FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics
• Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• 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…
  FDA Device · Class II · 2024-09-18 · Sol Millennium Medical
• IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and…
  FDA Device · Class II · 2024-09-18 · Ion Beam Applications
• Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR PROCEDURE, Pack Number CDS981509C
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number DYNJ0100999K
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
  FDA Device · Class II · 2024-09-18 · Biofire Diagnostics
• Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CDS980371J
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues
  FDA Device · Class II · 2024-09-18 · Smith And Nephew
• Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield
• Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequenc…
  FDA Device · Class II · 2024-09-18 · Olympus
• Medline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120
  FDA Device · Class II · 2024-09-18 · Medline Industries Northfield

Other years

2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)