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 Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) STERILE LIDOCAINE SYRINGE PACK, Pack Number DYNDM1076A
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline convenience kits containing semi-rigid suction liners labeled as follows: a) LAMINECTOMY CDS, Pack Number CDS981510L
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
FDA Device · Class II · 2024-09-18 · Zoe Medical - Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline convenience kits containing semi-rigid suction liners labeled as follows: a) MINOR BREAST, Pack Number DYNJ908104B
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) C-SECTION TRAY, Pack Number AM160B
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008
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 - Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proto…
FDA Device · Class II · 2024-09-18 · Hitachi America Particle Therapy Division - Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 o…
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number DYNJRA1023
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton…
FDA Device · Class II · 2024-09-18 · Hitachi America Particle Therapy Division - Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY TIFFIN C-SECTION, Pack Number DYNJ909732
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884
FDA Device · Class II · 2024-09-18 · Sol Millennium Medical - smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUperc Per…
FDA Device · Class I · 2024-09-18 · Smiths Medical Asd - Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Pro…
FDA Device · Class II · 2024-09-18 · Ultradent Products - Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
FDA Device · Class II · 2024-09-18 · Technomed Europe - Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and…
FDA Device · Class II · 2024-09-18 · Zimmer - Medline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or l…
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits, labeled as: BIOPSY TRAY-LF, Pack Number DYNDH1229
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral…
FDA Device · Class II · 2024-09-18 · Zimmer - ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP)
FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics - Medline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge
FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics - ROTATION MEDICAL TENDON STAPLES (8) (narrow 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: 1) GAS SAM LINE .06ID 10FT MM FLT, Pack Number 35772
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES TURNOVER KIT-LF, Pack Number DYNJAA10338J
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human seru…
FDA Device · Class II · 2024-09-18 · Siemens Healthcare Diagnostics - Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M
FDA Device · Class II · 2024-09-18 · Medline Industries Northfield - Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300
FDA Device · Class I · 2024-09-11 · Philips Respironics - Pump 371 14F LT CMR Set
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 SmartAssist Set, JP
FDA Device · Class II · 2024-09-11 · Abiomed - Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with control…
FDA Device · Class II · 2024-09-11 · Mindray Ds Usa - DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative dete…
FDA Device · Class II · 2024-09-11 · Beckman Coulter - Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require in…
FDA Device · Class I · 2024-09-11 · Breas Medical - Impella 5.5 SmartAssist S2 Set, JP
FDA Device · Class II · 2024-09-11 · Abiomed - Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, B…
FDA Device · Class II · 2024-09-11 · W L Gore And Associates - BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system
FDA Device · Class II · 2024-09-11 · Carefusion 303 - Impella CP Pump Set, Japan
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Smart Assist Set APAC
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 with SmartAssist S2 Set, EU
FDA Device · Class II · 2024-09-11 · Abiomed - Pump 381 Pump Set (US)
FDA Device · Class II · 2024-09-11 · Abiomed - Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with control…
FDA Device · Class II · 2024-09-11 · Mindray Ds Usa - Impella CP Pump 371 Set, Clinical Trial
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Smart Assist Set, EU
FDA Device · Class II · 2024-09-11 · Abiomed - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infu…
FDA Device · Class I · 2024-09-11 · Fresenius Kabi Usa - Trilogy Evo Universal Ventilator, Model No. DS2000X11B
FDA Device · Class I · 2024-09-11 · Philips Respironics - Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224
FDA Device · Class II · 2024-09-11 · Philips Medical Systems Nederland B V - ImpellaCP SmartAssistSetAPAC, Delo1895
FDA Device · Class II · 2024-09-11 · Abiomed - Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concent…
FDA Device · Class II · 2024-09-11 · Mindray Ds Usa - PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express
FDA Device · Class II · 2024-09-11 · Beckman Coulter Biomedical - Impella CP Smart Assist Set
FDA Device · Class II · 2024-09-11 · Abiomed - Power Express, REF B90918
FDA Device · Class II · 2024-09-11 · Beckman Coulter Biomedical - Impella 5.5 with SmartAssist S2 Set, US
FDA Device · Class II · 2024-09-11 · Abiomed - BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system
FDA Device · Class II · 2024-09-11 · Carefusion 303 - Impella CP Smart Assist Set, JP
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 with SmartAssist Set, CA
FDA Device · Class II · 2024-09-11 · Abiomed - PE Centrifuge, REF: B36365, a component of the Power Express
FDA Device · Class II · 2024-09-11 · Beckman Coulter Biomedical - Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB051501A BXB051502A BXB…
FDA Device · Class II · 2024-09-11 · W L Gore And Associates - Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentr…
FDA Device · Class II · 2024-09-11 · Mindray Ds Usa - Impella CP Smart Assist Set, Canada
FDA Device · Class II · 2024-09-11 · Abiomed - Trilogy Evo
FDA Device · Class I · 2024-09-11 · Philips Respironics - Impella 5.5 Set AU
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 with SmartAssist Set, US
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 with SmartAssist Set, EU
FDA Device · Class II · 2024-09-11 · Abiomed - PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Cod…
FDA Device · Class I · 2024-09-04 · Smiths Medical Asd - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001417
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - See RES Description
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedure packs containing Shenli syringes, labeled as follows: NEURO ANGIO PACK, Pack Number DYNDA1431A
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000828
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584545
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000455
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001478
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000120
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001331
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001338
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001138
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedural kits labeled as: 1) BIOPSY PACK, Pack Number DYNJ63370A
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - Medline procedural kits labeled as: 1) BOTOX KIT - CHRONIC MIGRAINE, Pack Number DYKM2000
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58002078
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived
FDA Device · Class II · 2024-09-04 · Abbott Diagnostics Technologies As
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)