FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085
FDA Device · Class II · 2023-11-01 · Omega Medical Imaging - SenSight Connector Plug, Model Number B31061
FDA Device · Class II · 2023-10-25 · Medtronic Neuromodulation - MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv
FDA Device · Class II · 2023-10-25 · Medline Industries Northfield - HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
FDA Device · Class II · 2023-10-25 · Access Vascular - Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
FDA Device · Class I · 2023-10-25 · Eitan Medical - Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right)…
FDA Device · Class II · 2023-10-25 · North Coast Medical - Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
FDA Device · Class II · 2023-10-25 · Cardinal Health 200 - DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
FDA Device · Class II · 2023-10-25 · Deroyal Industries - HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
FDA Device · Class II · 2023-10-25 · Access Vascular - Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery
FDA Device · Class I · 2023-10-25 · Olympus - stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
FDA Device · Class II · 2023-10-25 · Tornier - MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument
FDA Device · Class II · 2023-10-25 · Medline Industries Northfield - MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument
FDA Device · Class II · 2023-10-25 · Medline Industries Northfield - Functional MR V1.0
FDA Device · Class II · 2023-10-25 · Olea Medical - MEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF4418CR. electrosurgical instrument
FDA Device · Class II · 2023-10-25 · Medline Industries Northfield - 2008T GEN 2 Bibag without CDX
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) gener…
FDA Device · Class II · 2023-10-18 · Olympus - Access Thyroglobulin Calibrators
FDA Device · Class II · 2023-10-18 · Beckman Coulter - Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00
FDA Device · Class II · 2023-10-18 · Smiths Medical Asd - 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37…
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - Presource Fistulogram Pack, Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - Procedure packs: (1) Presource PBDS, Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - BD Pyxis CII Safe ES, REF: 1116-00
FDA Device · Class II · 2023-10-18 · Carefusion 303 - Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump
FDA Device · Class II · 2023-10-18 · Smiths Medical Asd - 2008T HD SYS. CDX BLUESTAR
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6
FDA Device · Class II · 2023-10-18 · Smiths Medical Asd - Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
FDA Device · Class II · 2023-10-18 · Techno Path Manufacturing - DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below
FDA Device · Class II · 2023-10-18 · Beckman Coulter - Procedure packs: (1) Presource PBDS Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
FDA Device · Class II · 2023-10-18 · Ansell Healthcare Products - 2008T Hemodialysis SYS, with CDX
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - Constellation Vision System, REF: 8065751150
FDA Device · Class II · 2023-10-18 · Alcon Research - GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
FDA Device · Class II · 2023-10-18 · Ansell Healthcare Products - BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
FDA Device · Class II · 2023-10-18 · Becton Dickinson And - Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-51, e) 0101-78, f) 0101-249, g) 0105-51, h) 0105-7…
FDA Device · Class II · 2023-10-18 · Smiths Medical Asd - 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
FDA Device · Class II · 2023-10-18 · Encore Medical - 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - Procedure packs: (1) Presource PBDS Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - 2008T HD SYS. W/O CDX BLUESTAR
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - 3T Heater Cooler System, REF: 16-02-85
FDA Device · Class II · 2023-10-18 · Livanova Deutschland - Procedure pack: Presource PBDS, Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - 2008T Hemodialysis System without CDX
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - Multichem P, Part Code 08P90-10
FDA Device · Class II · 2023-10-18 · Techno Path Manufacturing - 2008T Hemodialysis System w/Bibag
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - Procedure packs: (1) Presource PBDS, Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pump
FDA Device · Class II · 2023-10-18 · Smiths Medical Asd - Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
FDA Device · Class II · 2023-10-18 · Techno Path Manufacturing - Procedure packs: (1) Presource PBDS Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and subsequently open the intramedullary canal to the appro…
FDA Device · Class II · 2023-10-18 · Flower Orthopedics - Procedure packs: (1) Presource Portacath Pack, Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
FDA Device · Class II · 2023-10-18 · Encore Medical - 2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Device · Class I · 2023-10-18 · Fresenius Medical Care Holdings - MED-810A Zemits NDPrime Laser products
FDA Device · Class II · 2023-10-18 · Advance Esthetic - Procedure pack: Presource PBDS Cat
FDA Device · Class II · 2023-10-18 · Cardinal Health 200 - EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
FDA Device · Class II · 2023-10-18 · Encore Medical - Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
FDA Device · Class II · 2023-10-18 · Smiths Medical Asd - THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) gene…
FDA Device · Class II · 2023-10-18 · Olympus - CellQuicken Analyzer (Smart-Watch and Software), RoyalVibe Ultrasound Generator, Brainvibe, Envirovibe Water Restructuring Pad, RoyalVibe T…
FDA Device · Class II · 2023-10-18 · Royalvibe Health - MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
FDA Device · Class II · 2023-10-18 · Mazor Robotics - Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for…
FDA Device · Class II · 2023-10-11 · Getinge Usa Sales - Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A
FDA Device · Class I · 2023-10-11 · Arrow International - Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD,…
FDA Device · Class II · 2023-10-11 · Olympus - Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
FDA Device · Class II · 2023-10-11 · Blue Belt Technologies - Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refu…
FDA Device · Class II · 2023-10-11 · Ortho Clinical Diagnostics - Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Produc…
FDA Device · Class II · 2023-10-11 · Philips North America - Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm…
FDA Device · Class II · 2023-10-11 · Olympus - Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter¿ 90 Degree fo…
FDA Device · Class II · 2023-10-11 · Olympus - (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra…
FDA Device · Class II · 2023-10-11 · Siemens Medical Solutions Usa - EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Cod…
FDA Device · Class II · 2023-10-11 · Philips North America - Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2
FDA Device · Class I · 2023-10-11 · Arrow International - Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tra…
FDA Device · Class II · 2023-10-11 · Olympus - Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Citrine QTRAP Mass Spectrometer, Part Number 5063685
FDA Device · Class II · 2023-10-11 · Ab Sciex - Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Auro…
FDA Device · Class II · 2023-10-11 · Dkk Dai Ichi Shomei - Citrine Triple Quad Mass Spectrometer, Part Number 5063684
FDA Device · Class II · 2023-10-11 · Ab Sciex - Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - API3200MD Mass Spectrometer, Part Number 4466230
FDA Device · Class II · 2023-10-11 · Ab Sciex - Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
FDA Device · Class II · 2023-10-11 · Bard Peripheral Vascular - Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case
FDA Device · Class II · 2023-10-11 · Medline Industries Northfield - Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3 series, Aurora 4 series, Aurora Astro ser…
FDA Device · Class II · 2023-10-11 · Dkk Dai Ichi Shomei - Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System…
FDA Device · Class II · 2023-10-11 · Olympus - GS0008 2Y - Burn Pack - STL, Item Number 880082025
FDA Device · Class II · 2023-10-11 · Roi Cps - Incisive CT, software version 5.0
FDA Device · Class II · 2023-10-11 · Philips Healthcare - Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
FDA Device · Class II · 2023-10-11 · Boston Scientific - 4500MD Triple Quad Mass Spectrometer, Part Number 5032522
FDA Device · Class II · 2023-10-11 · Ab Sciex - Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into, or withdraw fluids from, parts of the body below the…
FDA Device · Class II · 2023-10-11 · Apellis Pharmaceuticals - Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc¿ Localization…
FDA Device · Class II · 2023-10-11 · Olympus - Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems
FDA Device · Class II · 2023-10-11 · Ge Medical Systems Israel
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)