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.
- Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #…
FDA Device · Class II · 2023-11-08 · Cosmedent - ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System
FDA Device · Class II · 2023-11-08 · Siemens Medical Solutions Usa - HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7…
FDA Device · Class II · 2023-11-08 · Baxter Healthcare - Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog…
FDA Device · Class I · 2023-11-08 · Asensus Surgical - Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork fo…
FDA Device · Class II · 2023-11-08 · Maquet Cardiovascular - McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
FDA Device · Class II · 2023-11-08 · Covidien - RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
FDA Device · Class II · 2023-11-08 · Randox Laboratories - McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
FDA Device · Class II · 2023-11-08 · Covidien - Coapt Dome Electrode, Gen2 system, cutaneous electrode
FDA Device · Class II · 2023-11-08 · Coapt - Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Device · Class I · 2023-11-08 · Covidien - RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
FDA Device · Class II · 2023-11-08 · Randox Laboratories - Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV…
FDA Device · Class II · 2023-11-08 · Quest Medical - Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
FDA Device · Class II · 2023-11-08 · Cepheid - RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
FDA Device · Class II · 2023-11-08 · Randox Laboratories - Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.…
FDA Device · Class II · 2023-11-08 · Nova Biomedical - Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200
FDA Device · Class II · 2023-11-08 · Siemens Medical Solutions Usa - Unity Total Knee System, Model Number 112.001.34
FDA Device · Class II · 2023-11-08 · Corin - Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD
FDA Device · Class II · 2023-11-08 · Cepheid - RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical inf…
FDA Device · Class II · 2023-11-08 · Raysearch Laboratories Ab - Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
FDA Device · Class II · 2023-11-08 · Abbott - AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
FDA Device · Class II · 2023-11-08 · Microvention - Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57…
FDA Device · Class II · 2023-11-08 · Nova Biomedical - Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
FDA Device · Class II · 2023-11-08 · Corin - RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900
FDA Device · Class II · 2023-11-08 · Randox Laboratories - LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40
FDA Device · Class II · 2023-11-08 · Medtronic Neuromodulation - Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile
FDA Device · Class II · 2023-11-08 · Smiths Medical Asd - Coapt ControlSeal Electrode, cutaneous EMG Electrode
FDA Device · Class II · 2023-11-08 · Coapt - To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10
FDA Device · Class II · 2023-11-01 · Universal Meditech - Cath Cardiac Pack, REF IHCC03V
FDA Device · Class II · 2023-11-01 · American Contract Systems - PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips
FDA Device · Class II · 2023-11-01 · Universal Meditech - Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa - Sub Q Recorder Pack, REF BPRC87A
FDA Device · Class II · 2023-11-01 · American Contract Systems - 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK
FDA Device · Class I · 2023-11-01 · B Braun Medical - PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
FDA Device · Class II · 2023-11-01 · Universal Meditech - Grafton DBM Putty, Model Numbers: a) T43102, b) T43102INT, c) T43103INT, d) T43105, e) T43105INT, f) T43110, g) T43110INT
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa - CVS PCSU SJH, REF SJCV48J
FDA Device · Class II · 2023-11-01 · American Contract Systems - HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP
FDA Device · Class II · 2023-11-01 · Universal Meditech - DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
FDA Device · Class II · 2023-11-01 · Universal Meditech - Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
FDA Device · Class I · 2023-11-01 · Cardinal Health 200 - Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1
FDA Device · Class II · 2023-11-01 · Ge Healthcare - Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation
FDA Device · Class II · 2023-11-01 · Ge Healthcare - Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
FDA Device · Class I · 2023-11-01 · Cardinal Health 200 - PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
FDA Device · Class II · 2023-11-01 · Universal Meditech - Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Device · Class II · 2023-11-01 · Universal Meditech - DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
FDA Device · Class II · 2023-11-01 · Universal Meditech - HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10
FDA Device · Class II · 2023-11-01 · Universal Meditech - Pediatric Heart SJH, REF SJPH34K
FDA Device · Class II · 2023-11-01 · American Contract Systems - General Pack, REF BBGP31C
FDA Device · Class II · 2023-11-01 · American Contract Systems - One Step Ovulation Test REF 200-01
FDA Device · Class II · 2023-11-01 · Universal Meditech - OMTMO One Step Ovulation (LH) Test Strips REF 200-07
FDA Device · Class II · 2023-11-01 · Universal Meditech - Grafton DBM Matrix Strips, Model Numbers: a) T42275, b) T42280
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa - Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
FDA Device · Class II · 2023-11-01 · Omega Medical Imaging - Robotics Pack SAH, REF SAR530M
FDA Device · Class II · 2023-11-01 · American Contract Systems - Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa - DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
FDA Device · Class II · 2023-11-01 · Universal Meditech - Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
FDA Device · Class II · 2023-11-01 · Smiths Medical Asd - Breast Plastics Pack, REF BBPL20D
FDA Device · Class II · 2023-11-01 · American Contract Systems - Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during…
FDA Device · Class II · 2023-11-01 · Empatica Srl - Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
FDA Device · Class I · 2023-11-01 · Cardinal Health 200 - DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
FDA Device · Class II · 2023-11-01 · Universal Meditech - Pediatric Urology Wolson Pack, REF BPPU55A
FDA Device · Class II · 2023-11-01 · American Contract Systems - Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only
FDA Device · Class II · 2023-11-01 · Preat - HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips
FDA Device · Class II · 2023-11-01 · Universal Meditech - Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
FDA Device · Class I · 2023-11-01 · Cardinal Health 200 - OPMI LUMERA 300, REF 6137
FDA Device · Class II · 2023-11-01 · Carl Zeiss Suzhou - Vasc
FDA Device · Class II · 2023-11-01 · American Contract Systems - PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
FDA Device · Class II · 2023-11-01 · Universal Meditech - Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision…
FDA Device · Class II · 2023-11-01 · Maquet Cardiovascular - DiagnosUS One Step LH Ovulation Test Strip REF 200-07
FDA Device · Class II · 2023-11-01 · Universal Meditech - HealthyWiser UriTest" UTI Test Strips REF 900-UTI
FDA Device · Class II · 2023-11-01 · Universal Meditech - Centricity Universal Viewer Workflow Manager, Image processing radiological system
FDA Device · Class II · 2023-11-01 · Ge Healthcare - Grafton DBM Orthoblend, Model Numbers: a) T44125INT, b) T44135, c) T44145, d) T44150
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa - JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262
FDA Device · Class II · 2023-11-01 · Smith And Nephew - PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
FDA Device · Class II · 2023-11-01 · Universal Meditech - Robotics Pack, REF SJVO56B
FDA Device · Class II · 2023-11-01 · American Contract Systems - Robotics Pack, REF SSRO22D
FDA Device · Class II · 2023-11-01 · American Contract Systems - SOZO Bilateral Arm L-Dex Software
FDA Device · Class II · 2023-11-01 · Impedimed - LAVH, REF BBLV21C
FDA Device · Class II · 2023-11-01 · American Contract Systems - Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only
FDA Device · Class II · 2023-11-01 · Preat - DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
FDA Device · Class II · 2023-11-01 · Universal Meditech - TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
FDA Device · Class II · 2023-11-01 · Acclarent - PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS
FDA Device · Class II · 2023-11-01 · Universal Meditech - JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262
FDA Device · Class II · 2023-11-01 · Smith And Nephew - Astral 100 and Astral 150 ventilators
FDA Device · Class I · 2023-11-01 · Resmed - Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa - Lem Fertility LH Ovulation Test (Strip) REF 200-07
FDA Device · Class II · 2023-11-01 · Universal Meditech - PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
FDA Device · Class II · 2023-11-01 · Universal Meditech - Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only
FDA Device · Class II · 2023-11-01 · Preat - Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3
FDA Device · Class II · 2023-11-01 · Ge Healthcare - Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
FDA Device · Class I · 2023-11-01 · Cardinal Health 200 - Universal Viewer Workflow Manager, Image processing radiological system
FDA Device · Class II · 2023-11-01 · Ge Healthcare - Grafton Plus DBM Paste, Model Numbers: a) T45001, b) T45005, c) T45010
FDA Device · Class II · 2023-11-01 · Medtronic Sofamor Danek Usa - Monoject 20 mL Syringe Luer-Lock Tip Soft Pack
FDA Device · Class I · 2023-11-01 · Cardinal Health 200 - DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
FDA Device · Class II · 2023-11-01 · Universal Meditech - DiagnosUS Pregnancy Test Midstream REF 100-17
FDA Device · Class II · 2023-11-01 · Universal Meditech - DiagnosUS Ovulation Predictor Midstream REF 200-17
FDA Device · Class II · 2023-11-01 · Universal Meditech - SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Device · Class II · 2023-11-01 · Syncardia Systems - One Step Pregnancy Test REF 100-01
FDA Device · Class II · 2023-11-01 · Universal Meditech - 8713051U, Infusomat Large Volume Pump, Wireless
FDA Device · Class I · 2023-11-01 · B Braun Medical - Lem Fertility hCG Pregnancy Urine Test REF 100-12
FDA Device · Class II · 2023-11-01 · Universal Meditech
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)