FDA Device · 2022
FDA Device recalls in 2022
RecallRadar indexes 2,191 FDA Device recall notices published in 2022. By classification: 168 Class I, 1,946 Class II, 77 Class III.
- Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
FDA Device · Class II · 2022-12-28 · Corin - HeartWare Model 1100
FDA Device · Class II · 2022-12-28 · Heartware - Vivid q N ultrasound
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and data from various imaging s…
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - Vivid S6 N ultrasound
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-0…
FDA Device · Class III · 2022-12-28 · Howmedica Osteonics - B125M Patient Monitor, REF 6160000-004-XXXXXX
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - HeartWare HVAD Pump Kit, REF MCS1705PU
FDA Device · Class II · 2022-12-28 · Heartware - Vivid S5 Ultrasound
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - Revaclear 400 Dialyzer
FDA Device · Class II · 2022-12-28 · Baxter Healthcare - The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to crea…
FDA Device · Class II · 2022-12-28 · Natus Medical - B125M Patient Monitor, REF 6160000-005-XXXXXXX
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - HeartWare HVAD Pump Kit, REF 1104JP
FDA Device · Class II · 2022-12-28 · Heartware - Revaclear 300 dialyzers
FDA Device · Class II · 2022-12-28 · Baxter Healthcare - Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - Vivid q ultrasound
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
FDA Device · Class II · 2022-12-28 · Convatec - Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
FDA Device · Class III · 2022-12-28 · Young Dental Manufacturing I - B125P Patient Monitor (with E-module slot option), REF 6160000-002
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - X-CORE 2 Ti Core, Static
FDA Device · Class II · 2022-12-28 · Nuvasive - Vivid i ultrasound
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - HeartWare HVAD Pump Kit, REF 1104CA-CLIN
FDA Device · Class II · 2022-12-28 · Heartware - HeartWare Model 1101
FDA Device · Class II · 2022-12-28 · Heartware - Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
FDA Device · Class II · 2022-12-28 · Abbott Molecular - HeartWare HVAD Pump Kit, REF 1104
FDA Device · Class II · 2022-12-28 · Heartware - Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L
FDA Device · Class II · 2022-12-28 · Tomy International - Vivid S6 ultrasound
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
FDA Device · Class II · 2022-12-28 · Devilbiss Healthcare - Revaclear 400 Dialyzer
FDA Device · Class II · 2022-12-28 · Baxter Healthcare - Medical Action Industries Inc
FDA Device · Class II · 2022-12-28 · Medical Action Industries 306 - Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
FDA Device · Class III · 2022-12-28 · Howmedica Osteonics - Revaclear 400 dialyzers
FDA Device · Class II · 2022-12-28 · Baxter Healthcare - 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1…
FDA Device · Class II · 2022-12-28 · Fresenius Medical Care Holdings - Vivid i N ultrasound
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - The product is a handheld ultraviolet-C germicidal wand and contains narrow-diameter, tubular lamps with a peak emission wavelength in the…
FDA Device · Class II · 2022-12-28 · Phonesoap - Revaclear 400 dialyzers
FDA Device · Class II · 2022-12-28 · Baxter Healthcare - B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - HeartWare HVAD Pump Kit, REF 1205
FDA Device · Class II · 2022-12-28 · Heartware - Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
FDA Device · Class II · 2022-12-28 · Corin - B105M Patient Monitor, REF 6160000-003
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA, MM…
FDA Device · Class II · 2022-12-28 · Companion Medical - HeartWare Model 1102
FDA Device · Class II · 2022-12-28 · Heartware - Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
FDA Device · Class II · 2022-12-28 · Medical Action Industries 306 - Vivid S5 N ultrasound
FDA Device · Class II · 2022-12-28 · Ge Medical Systems - Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
FDA Device · Class II · 2022-12-28 · Abbott Molecular - HeartWare HVAD Pump Kit, REF 1103
FDA Device · Class II · 2022-12-28 · Heartware - VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
FDA Device · Class II · 2022-12-28 · Icotec Ag - HENRY SCHEIN, Amnio Tray, Item No.570-3059
FDA Device · Class II · 2022-12-21 · Stradis Medical - STRADIS HEALTHCARE, Vein, Item No.682-1732
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal TOTAL HIP KIT, REF 89-9498.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal PAIN TRAY, REF 89-10464.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal BIOPSY PACK, REF 89-9614.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal TOTAL KNEE PACK, REF 89-9300.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Oncentra Brachy radiation therapy planning system software
FDA Device · Class II · 2022-12-21 · Elekta - DeRoyal BIOPSY PACK, REF 89-9739.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - DeRoyal BASIC NEURO PACK, REF 89-7258.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal GU PACK, REF 89-10665.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use…
FDA Device · Class II · 2022-12-21 · Ethicon - DeRoyal EYE TRAY, REF 89-4957.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal LAMINECTOMY PACK, REF 89-10209.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal SHOULDER ARTHORSCOPY PACK RF, REF 89-6628.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal CATARACT PACK, REF 89-9241.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228
FDA Device · Class II · 2022-12-21 · Stradis Medical - GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.13
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal CATARACT PACK, REF 89-9241.04
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal TOTAL HIP PACK, REF 89-9113.07
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal UNIVERSAL PACK, REF 89-9558.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SPINE PACK, REF 89-8361.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SHOULDER KIT, REF 89-9497.08
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02
FDA Device · Class II · 2022-12-21 · Deroyal Industries - STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890
FDA Device · Class II · 2022-12-21 · Stradis Medical - NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
FDA Device · Class II · 2022-12-21 · Zimmer - DeRoyal CUSTOM NEURO PACK, REF 89-7353.17
FDA Device · Class II · 2022-12-21 · Deroyal Industries - Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
FDA Device · Class I · 2022-12-21 · Arrow International - Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
FDA Device · Class II · 2022-12-21 · Leica Microsystems - DeRoyal CRANI PACK, REF 89-10202.05
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal SHOULDER ARTHROSCOPY PACK, REF 89-8777.04
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal EYE PACK, REF 89-4051.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal NEURO PACK, REF 89-10171.03
FDA Device · Class II · 2022-12-21 · Deroyal Industries - GEO-MED BIOPSY TRAY, REF 89-8753.01
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal CUSTOM NEURO PACK, REF 89-8392.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal KIT EXTREMITY PACK, REF 89-8869.09
FDA Device · Class II · 2022-12-21 · Deroyal Industries - HENRY SCHEIN, Vein Clinics 1, Item No.570-1426
FDA Device · Class II · 2022-12-21 · Stradis Medical - HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900
FDA Device · Class II · 2022-12-21 · Stradis Medical - DeRoyal LUMBAR/CERVICAL PACK, REF 89-9521.11
FDA Device · Class II · 2022-12-21 · Deroyal Industries - DeRoyal HEART PACK, REF 89-8351.11
FDA Device · Class II · 2022-12-21 · Deroyal Industries
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)