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.
- NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
FDA Device · Class II · 2022-06-08 · Medtronic Xomed - Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other condi…
FDA Device · Class II · 2022-06-08 · Ion Beam Applications - Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Nerve Block Tray Catalog Number: 8415
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Procedural Accessory Kit Catalog Number: 9665R2
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS
FDA Device · Class II · 2022-06-08 · Medline Industries Northfield - CVC Dressing Change Kit Catalog Number: 2491R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Joint Injection Tray Catalog Number: 8561R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Locking Cap for PD Catheter Adapter
FDA Device · Class II · 2022-06-08 · Baxter Healthcare - 3.2MM Pellet Insertion Tray Catalog Number: B1144
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
FDA Device · Class II · 2022-06-08 · Medline Industries Northfield - SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Universal Tray Catalog 1567
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
FDA Device · Class II · 2022-06-08 · Intuitive Surgical - SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Single Shot Epidural Tray Catalog 1292
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
FDA Device · Class II · 2022-06-08 · Bio Rad Laboratories - SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Pellet Insertion Tray Catalog Number: B1654
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - 15 Liters Drain Bag
FDA Device · Class II · 2022-06-08 · Baxter Healthcare - XVIVO Organ Chamber REF 19020
FDA Device · Class II · 2022-06-08 · Xvivo Perfusion Ab - Epidural Tray Catalog 1577
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - DYNEX Agility, Agility Analyzer, Model No. 67000
FDA Device · Class II · 2022-06-08 · Dynex Technologies - SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
FDA Device · Class II · 2022-06-08 · Microport Orthopedics - Nerve Block Tray Catalog Number: 9342
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Sterile Epidural Tray Catalog Number: 6259R2
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
FDA Device · Class II · 2022-06-08 · Medline Industries Northfield - Epidural Tray Catalog 1307
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Lumbar Tray Catalog 1091
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - I.V. Start Kit Catalog 8172
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Universal Nerve Block Tray Catalog Number: 9818
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
FDA Device · Class II · 2022-06-08 · Tornier - SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - DAVINCI
FDA Device · Class II · 2022-06-08 · Intuitive Surgical - Nerve Block Tray Catalog Number: 6796R3
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - BD Anti-Kappa APC (Cat
FDA Device · Class II · 2022-06-08 · Becton Dickinson And Bd Biosciences - SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Single Shot Epidural Tray Catalog Number: 6183R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Single Shot Epidural Tray Catalog Number: 6797R2
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Cervical Tray Catalog Number: 3765R2
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Core Biopsy Tray Catalog Number: 8673R4
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - In-Line ventilator adaptor
FDA Device · Class I · 2022-06-08 · Baxter Healthcare - MBB Tray Catalog Number: 9882
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
FDA Device · Class II · 2022-06-08 · Medtronic Xomed - In-Line ventilator adaptor
FDA Device · Class I · 2022-06-08 · Baxter Healthcare - Stereo Breast Biopsy Tray Catalog Number: 2383R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - 5 Prong Manifold Set (with Luer Connectors)
FDA Device · Class II · 2022-06-08 · Baxter Healthcare - SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Single Shot Epidural Tray Catalog Number: 8417
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - "3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Universal Nerve Block Tray Catalog Number: 9779
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Port Tray Catalog 7607
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Bone Marrow Biopsy Tray Catalog Number: 8917R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - SS 4.5MM Pellet Insertion Tray Catalog Number: B9807
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - 3.2MM Pellet Insertion Tray Catalog Number: B7345R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Pump Refill Kit Catalog Number: 7347R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable cath…
FDA Device · Class II · 2022-06-08 · Medtronic Cardiac Rhythm And Heart Failure Crhf - 3.2MM Pellet Insertion Tray Catalog Number: B9743
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Cervical Tray Catalog 1089
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Single Shot Epidural Tray Catalog 1165
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - 3,65 m Extension Set with Luer-lock Connector
FDA Device · Class II · 2022-06-08 · Baxter Healthcare - Procedure Tray Catalog 1065
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS
FDA Device · Class II · 2022-06-08 · Medline Industries Northfield - Pain Tray Catalog Number: 9883
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - Single Shot Epidural Tray - 18G Catalog Number: 8139R2
FDA Device · Class II · 2022-06-08 · Busse Hospital Disposables - HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
FDA Device · Class II · 2022-06-01 · Devicor Medical Products - ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
FDA Device · Class II · 2022-06-01 · Medline Industries Northfield - AC-powered adjustable medical beds with built-in electric DC actuators and controls
FDA Device · Class II · 2022-06-01 · Umano Medical - KWIK-STIK" plus: Clostridium perfringens
FDA Device · Class III · 2022-06-01 · Microbiologics - Percept BrainSense Implantable Neurostimulator (INS), Model B35200
FDA Device · Class II · 2022-06-01 · Medtronic Neuromodulation - Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
FDA Device · Class II · 2022-06-01 · Steris - The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade
FDA Device · Class II · 2022-06-01 · Accriva Diagnostics - Invacare TDX SP2, Model Nos
FDA Device · Class II · 2022-06-01 · Invacare - Sara Plus Active Floor Lift
FDA Device · Class I · 2022-06-01 · Arjohuntleigh Polska Sp Z O O - Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System
FDA Device · Class II · 2022-06-01 · Medtronic Perfusion Systems - INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
FDA Device · Class II · 2022-06-01 · Smith And Nephew Orthopaedics - (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile
FDA Device · Class II · 2022-06-01 · Teleflex Medical - Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
FDA Device · Class II · 2022-06-01 · Medtronic Neuromodulation - progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm
FDA Device · Class II · 2022-06-01 · Progenacare - Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Device · Class II · 2022-06-01 · Olympus - SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers
FDA Device · Class II · 2022-06-01 · Convatec - (1) Teleflex Flex tube, Product #20011, sterile
FDA Device · Class II · 2022-06-01 · Teleflex Medical - Vanta INS Implantable Neurostimulator
FDA Device · Class II · 2022-06-01 · Medtronic Neuromodulation - AC-powered adjustable medical beds with built-in electric DC actuators and controls
FDA Device · Class II · 2022-06-01 · Umano Medical - Surgical Suture Kit
FDA Device · Class II · 2022-06-01 · Stradis Healthcare - Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Indivi…
FDA Device · Class II · 2022-06-01 · International Science And Technology - Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
FDA Device · Class II · 2022-06-01 · Steris - CK MB Calibrator, Catalogue Number CK2393
FDA Device · Class III · 2022-05-25 · Randox Laboratories - Turbett Surgical Container, TS1500
FDA Device · Class II · 2022-05-25 · Turbett Surgical - EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for u…
FDA Device · Class II · 2022-05-25 · Boston Scientific
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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)