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.
- Product Name: TOTAL PLUS,25+ 7.5CPM VALVE Model/Catalog Number: 8065751617 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - Bag Decanter II, REF 2002S. 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 - DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination wit…
FDA Device · Class II · 2024-08-28 · Beckman Coulter Mishima K K - BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinami…
FDA Device · Class II · 2024-08-28 · Becton Dickinson And - Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE Model/Catalog Number: 8065983065 Software Version: N/A Product Description: Op…
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Catalog Number: 8065993047 Software Version: N/A Product Descript…
FDA Device · Class II · 2024-08-28 · Alcon Research - Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion pump) and…
FDA Device · Class II · 2024-08-28 · Baxter Healthcare - Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4 Model/Catalog Number: 8065772445 Software Version: N/A Product Description: Oph…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Name: 25+ TTL PLUS VPAK 20000CPM BWV Model/Catalog Number: 8065830077 Software Version: N/A Product Description: Standardized assem…
FDA Device · Class II · 2024-08-28 · Alcon Research - Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Device · Class II · 2024-08-28 · Covidien - Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
FDA Device · Class II · 2024-08-28 · Intrinsic Therapeutics - Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Bottle Decanter, REF 2004S. 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: 25+ CMB PAK 7.5CPM,V,STD 0.9 Model/Catalog Number: 8065751767 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Refere…
FDA Device · Class I · 2024-08-28 · Inari Medical Oak Canyon - Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Transfer Device, REF 2008S. 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 - The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side…
FDA Device · Class II · 2024-08-28 · Ortho Clinical Diagnostics - Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4 Model/Catalog Number: 8065772465 Software Version: N/A Product Description: Oph…
FDA Device · Class II · 2024-08-28 · Alcon Research - Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
FDA Device · Class II · 2024-08-28 · Alcon Research - Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932
FDA Device · Class II · 2024-08-28 · Medline Industries Northfield - Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic k…
FDA Device · Class II · 2024-08-28 · Alcon Research - BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous c…
FDA Device · Class II · 2024-08-21 · Biointellisense - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC (Pericardiocentesis Tr…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley adv…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Plum 360/A+ spare batteries
FDA Device · Class I · 2024-08-21 · Icu Medical - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introdu…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12…
FDA Device · Class I · 2024-08-21 · Icu Medical - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiograp…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - RMU-2000 Automated Chest Compression Device
FDA Device · Class I · 2024-08-21 · Defibtech - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit),…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Ang…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Discrete photometric chemistry analyzer for clinical use
FDA Device · Class II · 2024-08-21 · Beckman Coulter - Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in…
FDA Device · Class III · 2024-08-21 · Drg International - Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
FDA Device · Class I · 2024-08-21 · Icu Medical - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Mana…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed…
FDA Device · Class II · 2024-08-21 · Thoratec - BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution
FDA Device · Class II · 2024-08-21 · Becton Dickinson And - Aurora 4 Series, Aurora 7 lighthead
FDA Device · Class II · 2024-08-21 · Dkk Dai Ichi Shomei - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (A…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2024-08-21 · Argon Medical Devices - Cepheid, Sample Collection Device, Part: 900-0370
FDA Device · Class II · 2024-08-21 · Cepheid - VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
FDA Device · Class II · 2024-08-21 · Ortho Clinical Diagnostics - Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137
FDA Device · Class II · 2024-08-21 · Beckman Coulter - Aurora 2 Series, Aurora 7 lighthead
FDA Device · Class II · 2024-08-21 · Dkk Dai Ichi Shomei - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Mana…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (A…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Safety Paracentesis Proce…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introduce…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Moni…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Outake, REF CET200 and CE…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introduce…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02 (Custom Syringe Kit),…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Orthopantomograph OP300 dental computed tomography x-ray system
FDA Device · Class II · 2024-08-21 · Palodex Group Oy - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Ang…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressur…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Aurora 3 Series, Aurora 7 lighthead
FDA Device · Class II · 2024-08-21 · Dkk Dai Ichi Shomei - WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160
FDA Device · Class II · 2024-08-21 · Boston Scientific Neuromodulation - Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask…
FDA Device · Class II · 2024-08-21 · Eye Comfort Care - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09/K09T (Custom Manifold…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe Kit),…
FDA Device · Class II · 2024-08-21 · Merit Medical Systems - Aurora Series, Aurora 7 lighthead
FDA Device · Class II · 2024-08-21 · Dkk Dai Ichi Shomei - Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C
FDA Device · Class I · 2024-08-14 · Medline Industries Northfield - Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image
FDA Device · Class II · 2024-08-14 · Siemens Medical Solutions Usa - BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - SIGNA Prime, with affected software versions: MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - CADD-Solis Ambulatory Infusion Pumps, Model 2100
FDA Device · Class I · 2024-08-14 · Smiths Medical Asd - IntelliVue Patient Monitor MX400 with L.x and M.x
FDA Device · Class II · 2024-08-14 · Philips North America - Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - SIGNA MR355, with affected software versions: SV25.5, SV25.6
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
FDA Device · Class II · 2024-08-14 · Baxter Healthcare - Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ59089
FDA Device · Class I · 2024-08-14 · Medline Industries Northfield - Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image
FDA Device · Class II · 2024-08-14 · Siemens Medical Solutions Usa - BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F
FDA Device · Class I · 2024-08-14 · Medline Industries Northfield - (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared…
FDA Device · Class II · 2024-08-14 · Artivion - IntelliVue Patient Monitor MX550 with L.x and M.x
FDA Device · Class II · 2024-08-14 · Philips North America - American Contract Systems Gyn Laparoscopy convenience kit
FDA Device · Class II · 2024-08-14 · American Contract Systems - Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260
FDA Device · Class II · 2024-08-14 · Medline Industries Northfield - SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR3…
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Tot…
FDA Device · Class II · 2024-08-14 · American Contract Systems - BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
FDA Device · Class II · 2024-08-14 · Carefusion 303 - CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial…
FDA Device · Class I · 2024-08-14 · Smiths Medical Asd - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-01…
FDA Device · Class II · 2024-08-14 · Biofire Diagnostics - SIGNA Victor, with affected software versions: MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1
FDA Device · Class II · 2024-08-14 · Ge Medical Systems - Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope R…
FDA Device · Class II · 2024-08-14 · Steris - American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
FDA Device · Class II · 2024-08-14 · American Contract Systems - American Contract Systems Cataract Pack convenience kit
FDA Device · Class II · 2024-08-14 · American Contract Systems
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)