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.
- MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, Expiratory Filter, REF 2K8005F
FDA Device · Class I · 2024-03-06 · Vyaire Medical - Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art
FDA Device · Class II · 2024-03-06 · Medagent - Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
FDA Device · Class I · 2024-03-06 · Vyaire Medical - Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left
FDA Device · Class II · 2024-03-06 · Acumed - Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - INS7280 / Integra¿ Cranial Access Kit
FDA Device · Class II · 2024-03-06 · Integra Lifesciences - MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - AirLife Adult Manual Resuscitator, Variable Volume Oxygen Reservoir Tubing, Adult Mask, REF 2K8017
FDA Device · Class I · 2024-03-06 · Vyaire Medical - Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Colonoscope, Model Number CF-H180AL
FDA Device · Class II · 2024-03-06 · Olympus - MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
FDA Device · Class I · 2024-03-06 · Vyaire Medical - Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE1346D, c) ENDO KIT, REF DYK…
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Ref No: INS7260 / Integra¿ Cranial Access Kit
FDA Device · Class II · 2024-03-06 · Integra Lifesciences - Colonoscope, Model Number PCF-H190L
FDA Device · Class II · 2024-03-06 · Olympus - Colonoscope, Model Number PCF-H180AL
FDA Device · Class II · 2024-03-06 · Olympus - Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard
FDA Device · Class II · 2024-03-06 · Integra Lifesciences - Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fracture…
FDA Device · Class II · 2024-03-06 · Waldemar Link And Kg Mfg Site - Ref No: HITHSP04 / Integra Cranial Access Kit
FDA Device · Class II · 2024-03-06 · Integra Lifesciences - Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery - AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001
FDA Device · Class I · 2024-03-06 · Vyaire Medical - Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain
FDA Device · Class II · 2024-03-06 · Integra Lifesciences - MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Colonoscope, Model Number CF-HQ190I
FDA Device · Class II · 2024-03-06 · Olympus - AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, Adult Mask, REF 2K8004
FDA Device · Class I · 2024-03-06 · Vyaire Medical - IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300…
FDA Device · Class II · 2024-03-06 · Alphatec Spine - MEDLINE ARTERIAL BUNDLE NO CATHETER, REF ART995
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Ref No: HITHSP06 / Integra Cranial Access Kit
FDA Device · Class II · 2024-03-06 · Integra Lifesciences - Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap
FDA Device · Class II · 2024-03-06 · Emd Millipore - USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 1…
FDA Device · Class II · 2024-03-06 · United Orthopedic - Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - NxStage Cartridge Express with Speedswap, Catalog No. CAR-535
FDA Device · Class II · 2024-03-06 · Nxstage Mds - Ref No: INS7250 / Integra Cranial Access Kit
FDA Device · Class II · 2024-03-06 · Integra Lifesciences - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery - Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Ref No: INSHITHRZN / Integra Cranial Access Kit
FDA Device · Class II · 2024-03-06 · Integra Lifesciences - Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Colonoscope, Model Number PCF-H190DL
FDA Device · Class II · 2024-03-06 · Olympus - In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010
FDA Device · Class III · 2024-03-06 · Abbott Molecular - MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Colonoscope, Model Number PCF-Q180AL
FDA Device · Class II · 2024-03-06 · Olympus - Colonoscope, Model Number PCF-H190TL
FDA Device · Class II · 2024-03-06 · Olympus - Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
FDA Device · Class I · 2024-03-06 · Vyaire Medical - Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Colonoscope, Model Number CF-HQ190L
FDA Device · Class II · 2024-03-06 · Olympus - Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery - USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213…
FDA Device · Class II · 2024-03-06 · United Orthopedic - In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020
FDA Device · Class III · 2024-03-06 · Abbott Molecular - Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089
FDA Device · Class II · 2024-03-06 · Graphenano Dental Sl - Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A
FDA Device · Class I · 2024-03-06 · Medline Industries Northfield - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery - Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
FDA Device · Class I · 2024-02-28 · Windstone Medical Packaging - Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems
FDA Device · Class II · 2024-02-28 · Philips Medical Systems Nederland B V - OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
FDA Device · Class II · 2024-02-28 · Impulse Dynamics Usa - Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD
FDA Device · Class I · 2024-02-28 · Cardinal Health 200 - Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY
FDA Device · Class I · 2024-02-28 · Cardinal Health 200 - Epidural tray
FDA Device · Class II · 2024-02-28 · B Braun Medical - GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm
FDA Device · Class II · 2024-02-28 · W L Gore And Associates - Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
FDA Device · Class I · 2024-02-28 · Windstone Medical Packaging - HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
FDA Device · Class II · 2024-02-28 · Amd Medicom - Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT
FDA Device · Class I · 2024-02-28 · Cardinal Health 200 - Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images
FDA Device · Class II · 2024-02-28 · Fujifilm Healthcare Americas - Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system
FDA Device · Class II · 2024-02-28 · Philips Medical Systems Nederland B V - Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images
FDA Device · Class II · 2024-02-28 · Fujifilm Healthcare Americas - Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected syst…
FDA Device · Class II · 2024-02-28 · Philips Medical Systems Nederland B V - Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (ca…
FDA Device · Class II · 2024-02-28 · Abiomed - Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD
FDA Device · Class I · 2024-02-28 · Cardinal Health 200 - Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Mode…
FDA Device · Class II · 2024-02-28 · Philips Medical Systems Nederland B V
Other years
2026 (2,088) · 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)