FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - KD-650U ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - NEEDLEMASTER 6MMx 23G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to p…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, p…
FDA Device · Class II · 2021-02-17 · Draegar Medical Systems - INJECTOR FORCEMAX LOWER 23G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - KD-611L ELECTROSURGICAL KNIFE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NA-401D-1521 ASPIRATION NEEDLE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX LOWER 25G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - EMBLEM S-ICD Model A209
FDA Device · Class I · 2021-02-17 · Boston Scientific - NEEDLEMASTER 5MMx 21G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 4MMx 23G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - KD-650L ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices - Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrie…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - KD-640L ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barri…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERIL…
FDA Device · Class II · 2021-02-17 · Prytime Medical Devices - CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - NEEDLEMASTER 3MMx 26G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 6MMx 21G UPPER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The i…
FDA Device · Class II · 2021-02-17 · Icu Medical - B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or su…
FDA Device · Class II · 2021-02-17 · Arrow International - INJECTOR FORCEMAX 25G 2.5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 3MMx 23G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NA-601D-1519 ASPIRATION NEEDLE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - PR-V614M 2-LUMEN CANNULA, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 23G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive…
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - KD-612U ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products
FDA Device · Class II · 2021-02-17 · Depuy Orthopaedics - Aquarius LPH 511-A CRLF2 Distal Probe Green, model no
FDA Device · Class II · 2021-02-17 · Cytocell - NA-411D-1321 ASPIRATION NEEDLE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive…
FDA Device · Class II · 2021-02-17 · Aomori Olympus - CRESCENT SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - PBD-203-0707 BILIARY STENT, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - K-204 GUIDE SHEATH KIT 2.6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - EMBLEM MRI S-ICD Model A219
FDA Device · Class I · 2021-02-17 · Boston Scientific - KD-655U ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - KD-620LR ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX LOWER 25G 2.5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - NEEDLEMASTER 1.8MMx 26G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - PBD-203-0703 BILIARY STENT, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use,…
FDA Device · Class II · 2021-02-17 · Icu Medical - SD-240U-15 ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices - INJECTOR FORCEMAX LOWER 23G 5MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barri…
FDA Device · Class II · 2021-02-17 · Cardinal Health 200 - CRESCENT SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices - SD-210U-10 ELECTROSURGICAL SNARE, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved M…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices - NEEDLEMASTER 3MMx 23G LOWER, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - K-203 GUIDE SHEATH KIT 2.6MM, model no
FDA Device · Class II · 2021-02-17 · Aomori Olympus - Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used i…
FDA Device · Class II · 2021-02-10 · Mar Med - FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm)
FDA Device · Class II · 2021-02-10 · Baxter Healthcare - Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infect…
FDA Device · Class III · 2021-02-10 · Biomeme - Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilit…
FDA Device · Class I · 2021-02-10 · Hill Rom - Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professiona…
FDA Device · Class II · 2021-02-10 · Topcon Medical Systems - Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A
FDA Device · Class II · 2021-02-10 · The Binding Site Group - ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf inf…
FDA Device · Class II · 2021-02-10 · Alung Technologies - Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgica…
FDA Device · Class II · 2021-02-10 · Ethicon - Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi -…
FDA Device · Class II · 2021-02-10 · Philips Ultrasound - SARS-CoV-2 Antigen Test
FDA Device · Class II · 2021-02-10 · Qiagen Sciences - REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
FDA Device · Class II · 2021-02-10 · Allergan - Philips EPIQ Diagnostic Ultrasound System
FDA Device · Class II · 2021-02-10 · Philips Ultrasound - Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, an…
FDA Device · Class II · 2021-02-10 · Brainreader Aps - VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscos…
FDA Device · Class II · 2021-02-10 · Smith And Nephew - Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9
FDA Device · Class II · 2021-02-10 · Fresenius Medical Care Holdings - Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Mo…
FDA Device · Class I · 2021-02-10 · Heartware - Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307
FDA Device · Class II · 2021-02-10 · Riverpoint Medical - Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respiron…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a…
FDA Device · Class II · 2021-02-03 · Becton Dickinson And - BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a s…
FDA Device · Class II · 2021-02-03 · Becton Dickinson And - Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics…
FDA Device · Class II · 2021-02-03 · Respironics California - Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-r…
FDA Device · Class II · 2021-02-03 · Respironics California - EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System
FDA Device · Class II · 2021-02-03 · Boston Scientific
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)