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.
- Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These…
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
FDA Device · Class II · 2024-10-30 · Baxter Healthcare - Baxter Operating Table TruSystem 7000, Product code REF 1841046
FDA Device · Class II · 2024-10-30 · Baxter Healthcare - Aespire 100
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
FDA Device · Class II · 2024-10-30 · Ad Tech Medical Instrument - medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
FDA Device · Class II · 2024-10-30 · Ad Tech Medical Instrument - medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - SynchroMed II Infusion Pump
FDA Device · Class II · 2024-10-30 · Medtronic Neuromodulation - medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
FDA Device · Class II · 2024-10-30 · Baxter Healthcare - Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF, REF DYNJ0912449M
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
FDA Device · Class II · 2024-10-30 · Baxter Healthcare - medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes…
FDA Device · Class II · 2024-10-30 · Blue Ortho - Diasol Acid Concentrate REF G100325-10Dex 100
FDA Device · Class II · 2024-10-30 · Diasol - medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
FDA Device · Class II · 2024-10-30 · Olympus - Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - bk3000, model #2300-11
FDA Device · Class II · 2024-10-30 · B K Medical A S - Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
FDA Device · Class II · 2024-10-30 · Baxter Healthcare - smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline DENTAL PACK, REF DYNJ64086B
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft…
FDA Device · Class II · 2024-10-30 · Olympus - medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline DIALYSIS PACK, REF DYNJ36932A
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis…
FDA Device · Class II · 2024-10-30 · Mckesson Medical Surgical Corporate Office - Aespire 7900
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing d…
FDA Device · Class II · 2024-10-30 · Polymer Technology Systems - Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR - UMBILICAL CUT DOWN TRA, b) PLASTICS SUTURE TRAY
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor applic…
FDA Device · Class II · 2024-10-30 · Boston Scientific - medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
FDA Device · Class II · 2024-10-30 · Baxter Healthcare - smiths medical portex, Y' PIECE 15MM, REF 100/276/000
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing
FDA Device · Class II · 2024-10-30 · Spectrum Medical - Centurion OB TRAY, REF MNS13965A
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Avance CS2 and Avance CS2 Pro
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - Medline CHEST TUBE INSERTION TRAY ADUL, REF CHT1165
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK, REF DYNJ42735A
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components:…
FDA Device · Class II · 2024-10-30 · Shimadzu Medical Systems Division - Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) B…
FDA Device · Class I · 2024-10-30 · Baxter Healthcare - Avance
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Aisys CS2 with Et Control
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786
FDA Device · Class II · 2024-10-30 · Baxter Healthcare - Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of so…
FDA Device · Class II · 2024-10-30 · Olympus - Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline AMBULATORY MINI PACK, REF DYNJ82579
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline TUBAL LIGATION PACK, REF DYNJ66230B
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Aespire View
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - Centurion EP LAB INSTRUMENT KIT, REF MNS10480
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300
FDA Device · Class II · 2024-10-30 · Medtronic Neuromodulation - Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
FDA Device · Class II · 2024-10-30 · Baxter Healthcare - Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Aisys
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to…
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS, REF CDS982519W
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - (1) Centurion Sterile CirClamp, Reorder #200CR
FDA Device · Class II · 2024-10-30 · Medline Industries Northfield - Amingo
FDA Device · Class I · 2024-10-30 · Datex Ohmeda - medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242
FDA Device · Class II · 2024-10-30 · Smiths Medical Asd - Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2
FDA Device · Class II · 2024-10-23 · Leica Biosystems Nussloch - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US
FDA Device · Class II · 2024-10-23 · Boston Scientific - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN
FDA Device · Class II · 2024-10-23 · Boston Scientific - MEDLINE HEART CABG CDS, REF CDS983376R
FDA Device · Class II · 2024-10-23 · Medline Industries Northfield - basixTOUCH Inflation Device, REF: IN8140/A
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, An…
FDA Device · Class II · 2024-10-23 · Merit Medical Systems - Change Healthcare Cardiology Hemo
FDA Device · Class II · 2024-10-23 · Change Healthcare Canada
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)