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.
- NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects
FDA Device · Class II · 2022-03-30 · Ace Surgical Supply - TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome C…
FDA Device · Class III · 2022-03-30 · Cytocell - Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tenne…
FDA Device · Class II · 2022-03-30 · Dollar Tree Distribution - BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008
FDA Device · Class II · 2022-03-30 · Biomet - Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/o…
FDA Device · Class II · 2022-03-30 · Integra Lifesciences - Compella Therapy Air Supply Unit
FDA Device · Class II · 2022-03-30 · Baxter Healthcare - Azurion systems with software release R2.0.x
FDA Device · Class II · 2022-03-30 · Philips Healthcare - BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
FDA Device · Class II · 2022-03-23 · Bio Rad Laboratories - HYDRATOME RX 44-30MM/260CM Material Number: M00583050
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME RX 44-20-260-035 Material Number: M00573040
FDA Device · Class II · 2022-03-23 · Boston Scientific - LUMBAR PUNCTURE TRAY ADULT 18G X 3.5
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
FDA Device · Class II · 2022-03-23 · Boston Scientific - 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box
FDA Device · Class III · 2022-03-23 · Cellera - HYDRATOME RX 49-30MM/260CM Material Number: M00583010
FDA Device · Class II · 2022-03-23 · Boston Scientific - HYDRATOME RX 44-30MM/450CM Material Number: M00583070
FDA Device · Class II · 2022-03-23 · Boston Scientific - 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box
FDA Device · Class III · 2022-03-23 · Cellera - SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
FDA Device · Class II · 2022-03-23 · Boston Scientific - Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the f…
FDA Device · Class II · 2022-03-23 · Siemens Medical Solutions Usa - JAGTOME RX 39-20-450-025 Material Number: M00573090
FDA Device · Class II · 2022-03-23 · Boston Scientific - DREAMTOME 44-30MM/260CM Material Number: M00584050
FDA Device · Class II · 2022-03-23 · Boston Scientific - DREAMTOME 49-20MM/260CM Material Number: M00584000
FDA Device · Class II · 2022-03-23 · Boston Scientific - LUMBAR PUNCTURE DRUG FREE TRAY 22G
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - HYDRATOME RX 44-20MM/260CM Material Number: M00583040
FDA Device · Class II · 2022-03-23 · Boston Scientific - ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box
FDA Device · Class III · 2022-03-23 · Cellera - JAGTOME RX 44-30-260-035 Material Number: M00573060
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
FDA Device · Class II · 2022-03-23 · Boston Scientific - Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration
FDA Device · Class III · 2022-03-23 · Livanova Deutschland - SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
FDA Device · Class III · 2022-03-23 · Cellera - RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M00575440 M00575480
FDA Device · Class II · 2022-03-23 · Boston Scientific - LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - JAGTOME RX 49-30-260-035 Material Number: M00573020
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
FDA Device · Class II · 2022-03-23 · Boston Scientific - LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhea…
FDA Device · Class II · 2022-03-23 · Hill Rom - ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
FDA Device · Class II · 2022-03-23 · Sam Medical Products - Wright Medical Technology, Inc
FDA Device · Class II · 2022-03-23 · Wright Medical Technology - DREAMTOME 49-20MM/450CM Material Number: M00584020
FDA Device · Class II · 2022-03-23 · Boston Scientific - LYFO Disk
FDA Device · Class III · 2022-03-23 · Microbiologics - JAGTOME RX 49-30-450-035 Material Number: M00573030
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME RX 39-30-260-025 Material Number: M00573100
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME RX 39-20-260-025 Material Number: M00573080
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME RX 44-20-450-035 Material Number: M00573050
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME RX 44-30-450-035 Material Number: M00573070
FDA Device · Class II · 2022-03-23 · Boston Scientific - BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
FDA Device · Class II · 2022-03-23 · Bio Rad Laboratories - Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - HYDRATOME RX 49-20MM/260CM Material Number: M00583000
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME RX 49-20-260-035 Material Number: M00573000
FDA Device · Class II · 2022-03-23 · Boston Scientific - DREAMTOME 49-30MM/450CM Material Number: M00584030
FDA Device · Class II · 2022-03-23 · Boston Scientific - LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnos…
FDA Device · Class II · 2022-03-23 · Abbott Laboratories - Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
FDA Device · Class II · 2022-03-23 · Boston Scientific - 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box
FDA Device · Class III · 2022-03-23 · Cellera - STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of S…
FDA Device · Class I · 2022-03-23 · Sd Biosensor - DREAMTOME 49-30MM/260CM Material Number: M00584010
FDA Device · Class II · 2022-03-23 · Boston Scientific - HYDRATOME RX 44-20MM/450CM Material Number: M00583060
FDA Device · Class II · 2022-03-23 · Boston Scientific - Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
FDA Device · Class II · 2022-03-23 · Boston Scientific - JAGTOME RX 39-30-450-025 Material Number: M00573110
FDA Device · Class II · 2022-03-23 · Boston Scientific - GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001
FDA Device · Class II · 2022-03-23 · Ge Healthcare - LINQ II Insertable Cardiac Monitor
FDA Device · Class II · 2022-03-23 · Medtronic Cardiac Rhythm And Heart Failure Crhf - DREAMTOME 44-30MM/450CM Material Number: M00584070
FDA Device · Class II · 2022-03-23 · Boston Scientific - Mycoplasma genitalium Control Panel (Inactivated Pellet)
FDA Device · Class II · 2022-03-23 · Microbiologics - JAGTOME RX 39-30-260-025 Material Number: M00573100
FDA Device · Class II · 2022-03-23 · Boston Scientific - Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagen…
FDA Device · Class II · 2022-03-23 · Hologic - SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
FDA Device · Class II · 2022-03-23 · Bard Peripheral Vascular - Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of th…
FDA Device · Class II · 2022-03-16 · Nextremity Solutions - PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
FDA Device · Class II · 2022-03-16 · 3 D Matrix - HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm
FDA Device · Class II · 2022-03-16 · Maquet Cardiovascular - ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other con…
FDA Device · Class II · 2022-03-16 · Ion Beam Applications - ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST
FDA Device · Class II · 2022-03-16 · Brainlab Ag - CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
FDA Device · Class II · 2022-03-16 · Carl Zeiss Meditec - Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Numbe…
FDA Device · Class II · 2022-03-16 · Cytocell - RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy
FDA Device · Class II · 2022-03-16 · Raysearch Laboratories Ab - Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
FDA Device · Class II · 2022-03-16 · Celltrion Usa - HeartWare Ventricular Assist Device (HVAD) System
FDA Device · Class II · 2022-03-16 · Heartware - LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
FDA Device · Class I · 2022-03-16 · Lusys Laboratories - Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
FDA Device · Class I · 2022-03-16 · Lusys Laboratories - 1688 Camera Control Unit (CCU), Catalog number:1688010000
FDA Device · Class II · 2022-03-16 · Stryker - Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve
FDA Device · Class II · 2022-03-16 · B Braun Medical - Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722…
FDA Device · Class II · 2022-03-16 · Philips North America - CoolSeal Generator, REF: CSL-200-50
FDA Device · Class II · 2022-03-16 · Bolder Surgical - Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature
FDA Device · Class I · 2022-03-16 · Ev3 - Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
FDA Device · Class II · 2022-03-16 · Remel - NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947)
FDA Device · Class II · 2022-03-16 · Neumodx Molecular - PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact uni…
FDA Device · Class II · 2022-03-16 · Envisiontec Us - NIM TRIVANTAGE EMG Endotracheal Tube
FDA Device · Class II · 2022-03-16 · Medtronic Xomed - Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an exten…
FDA Device · Class II · 2022-03-16 · Philips North America - COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
FDA Device · Class I · 2022-03-16 · Lusys Laboratories - VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box
FDA Device · Class II · 2022-03-16 · Ortho Clinical Diagnostics - Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of t…
FDA Device · Class II · 2022-03-16 · Nextremity Solutions - Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature
FDA Device · Class I · 2022-03-16 · Ev3 - HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
FDA Device · Class III · 2022-03-16 · Physio Control - Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
FDA Device · Class II · 2022-03-09 · Biopro - Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
FDA Device · Class II · 2022-03-09 · Shimadzu Medical Systems - QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture)
FDA Device · Class II · 2022-03-09 · Microbiologics - NavitrackER Kit A: Knee, Model Number 20-8000-000-07
FDA Device · Class II · 2022-03-09 · Orthosoft - Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
FDA Device · Class II · 2022-03-09 · Roi Cps
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)