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.
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001838
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: 58001845
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: 58001809
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shap…
FDA Device · Class II · 2024-09-04 · Stryker - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 584404
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - Medline procedural kits labeled as: 1) BABY CARE KIT UNIV, Pack Number DYKL1025
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: 58001314
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
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: 58001526
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: 58001973
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: 58001305
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: 58000288
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: 58000479
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: 58001624
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: 58002063
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: 58001375
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: 58001943
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: 58001649
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: 58000749
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 6…
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: 58001753
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: 58001706
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKST…
FDA Device · Class I · 2024-09-04 · Smiths Medical Asd - Centurion procedure kits labeled as: UMBILICAL VESSEL TRAY, Pack Number UVT1100
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: 58000813
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A
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: 58001795
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349
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: 58001774
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025
FDA Device · Class I · 2024-09-04 · Smiths Medical Asd - Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B
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: 58001503
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: 58001048
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline convenience kits, labeled as: 1) PAIN SERVICES CDS , Pack Number CDS985445B
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - DxI 9000 Access Immunoassay Analyzer, Catalog #C11137
FDA Device · Class II · 2024-09-04 · Beckman Coulter - PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/It…
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: 58001579
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Medline procedural kits labeled as: 1) SR C SECTION, Pack Number DYNJ908584
FDA Device · Class II · 2024-09-04 · Medline Industries Northfield - Centurion procedure packs, containing Caina syringes, labeled as: SHAVE KIT, Pack Number MNS8250
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: 58001622
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: 584003
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - Product Name: TOTAL PLUS,25+,10K VALVE STD Model/Catalog Number: 8065752437 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.75MM ANG DUA Model/Catalog Number: 8065992747 Software Version: N/A Product Descript…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product…
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Descript…
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289F
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 Software Version: N/A Product Description: Valved Trocar Entry…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Catalog Number: 8065992761 Software Version: N/A Product Descript…
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-designe…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992245 Software Version: N/A Product Description: Ophtha…
FDA Device · Class II · 2024-08-28 · Alcon Research - BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
FDA Device · Class II · 2024-08-28 · Biofire Diagnostics - 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs)
FDA Device · Class II · 2024-08-28 · Microtek Medical - Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description:…
FDA Device · Class II · 2024-08-28 · Alcon Research - LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog Number: 8065983265 Software Version: N/A Product Description: Op…
FDA Device · Class II · 2024-08-28 · Alcon Research - Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
FDA Device · Class II · 2024-08-28 · Philips Medical Systems Nederland B V - C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs)
FDA Device · Class II · 2024-08-28 · Microtek Medical - Regard Kit containing the Microtek decanter
FDA Device · Class II · 2024-08-28 · Roi Cps - Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992445 Software Version: N/A Product Description: Ophtha…
FDA Device · Class II · 2024-08-28 · Alcon Research - Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
FDA Device · Class II · 2024-08-28 · Stryker Sustainability Solutions - Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2 Model/Catalog Number: 8065772265 Software Version: N/A Product Description: Oph…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Oph…
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Catalog Number: 8065993045 Software Version: N/A Product Descript…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Produc…
FDA Device · Class II · 2024-08-28 · Alcon Research - LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE2.6MM ANG DUAL Model/Catalog Number: 8065992647 Software Version: N/A Product Descript…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG Model/Catalog Number: 8065990002 Software Version: N/A Product Descript…
FDA Device · Class II · 2024-08-28 · Alcon Research - GM60A. Digital Diagnostic Mobile X-Ray System
FDA Device · Class II · 2024-08-28 · Neurologica - Alinity hq Analyzer, REF: 09P68-01
FDA Device · Class II · 2024-08-28 · Abbott Laboratories - Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065982465 Software Version: N/A Product…
FDA Device · Class II · 2024-08-28 · Alcon Research - McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
FDA Device · Class I · 2024-08-28 · Covidien - 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-comp…
FDA Device · Class II · 2024-08-28 · Preat - Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version: N/A Product Descript…
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
FDA Device · Class II · 2024-08-28 · Ventana Medical Systems - Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pu…
FDA Device · Class II · 2024-08-28 · Baxter Healthcare - Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors…
FDA Device · Class II · 2024-08-28 · Ion Beam Applications - Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophtha…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG Model/Catalog Number: 8065772745 Software Version: N/A Product Description: O…
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
FDA Device · Class I · 2024-08-28 · Covidien - Product Name: 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU Model/Catalog Number: 8065000095 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
FDA Device · Class II · 2024-08-28 · Biofire Diagnostics - Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOWER ENDO K…
FDA Device · Class II · 2024-08-28 · 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)