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.
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac outpu…
FDA Device · Class II · 2021-01-20 · Icu Medical - Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies So…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 087147299…
FDA Device · Class I · 2021-01-20 · Boston Scientific - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: fo…
FDA Device · Class II · 2021-01-20 · Clerio Vision - Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3…
FDA Device · Class II · 2021-01-20 · Ortho Clinical Diagnostics - Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens
FDA Device · Class II · 2021-01-20 · Siemens Healthcare Diagnostics - Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for…
FDA Device · Class II · 2021-01-20 · Medtronic Neuromodulation - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications…
FDA Device · Class II · 2021-01-20 · Siemens Medical Solutions Usa - Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
FDA Device · Class II · 2021-01-20 · Siemens Medical Solutions Usa - Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical C…
FDA Device · Class II · 2021-01-20 · Visby Medical - Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
FDA Device · Class II · 2021-01-20 · Cook Medical - Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applicati…
FDA Device · Class II · 2021-01-20 · Siemens Medical Solutions Usa - Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sod…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 087147299…
FDA Device · Class I · 2021-01-20 · Boston Scientific - AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC…
FDA Device · Class II · 2021-01-20 · Ansh Labs - Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisoto…
FDA Device · Class II · 2021-01-20 · Ge Healthcare - VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolaps…
FDA Device · Class II · 2021-01-20 · Baxter Healthcare - NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies S…
FDA Device · Class II · 2021-01-20 · Fresenius Medical Care Holdings - Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 0871472…
FDA Device · Class I · 2021-01-20 · Boston Scientific - Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens
FDA Device · Class II · 2021-01-20 · Siemens Healthcare Diagnostics - Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - Vis-U-All High Temperature Tubing 4"x100'. One roll per box
FDA Device · Class II · 2021-01-13 · Steris - Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usag…
FDA Device · Class II · 2021-01-13 · Linet Spol S R O - Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Greffe Aorte-LF (product info is in French)
FDA Device · Class II · 2021-01-13 · Medline Industries - Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation…
FDA Device · Class II · 2021-01-13 · Boston Scientific - TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radi…
FDA Device · Class II · 2021-01-13 · Accuray - Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 1…
FDA Device · Class II · 2021-01-13 · Depuy Orthopaedics - CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such…
FDA Device · Class II · 2021-01-13 · Roche Diagnostics Operations - CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring…
FDA Device · Class II · 2021-01-13 · Roche Diagnostics Operations - Vis-U-All High Temperature Tubing 3"x100'. One roll per box
FDA Device · Class II · 2021-01-13 · Steris - enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative…
FDA Device · Class II · 2021-01-13 · Ortho Clinical Diagnostics - Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdomin…
FDA Device · Class II · 2021-01-13 · Medline Industries - Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - MiniCap Extended Life PD Transfer Set
FDA Device · Class II · 2021-01-13 · Baxter Healthcare - Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for im…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for im…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Resect
FDA Device · Class II · 2021-01-13 · Medline Industries - VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytica…
FDA Device · Class II · 2021-01-13 · Ortho Clinical Diagnostics - Vis-U-All High Temperature Tubing 6"x100'. One roll per box
FDA Device · Class II · 2021-01-13 · Steris - Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, ab…
FDA Device · Class II · 2021-01-13 · Medline Industries - TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, ster…
FDA Device · Class II · 2021-01-13 · Accuray - Vis-U-All High Temperature Tubing 9"x100'. One roll per box
FDA Device · Class II · 2021-01-13 · Steris - VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge) Product Code:8058232 (2)VITROS CKMB Slides (18 Slide cart…
FDA Device · Class II · 2021-01-13 · Ortho Clinical Diagnostics - Bone fixation nail
FDA Device · Class II · 2021-01-13 · Smith And Nephew - Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box
FDA Device · Class II · 2021-01-13 · Steris - Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for im…
FDA Device · Class II · 2021-01-13 · Boston Scientific - Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdo…
FDA Device · Class II · 2021-01-13 · Medline Industries - BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to th…
FDA Device · Class II · 2021-01-06 · Becton Dickinson And - Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discret…
FDA Device · Class II · 2021-01-06 · Roche Diagnostics Operations - BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to…
FDA Device · Class II · 2021-01-06 · Becton Dickinson And - Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only
FDA Device · Class II · 2021-01-06 · Medtronic Neurosurgery - Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems
FDA Device · Class II · 2021-01-06 · Intersurgical - Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty
FDA Device · Class II · 2021-01-06 · Merit Medical Systems - Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and th…
FDA Device · Class II · 2021-01-06 · Covidien - REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intende…
FDA Device · Class II · 2021-01-06 · Westmed - REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only,…
FDA Device · Class II · 2021-01-06 · Westmed - REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient
FDA Device · Class II · 2021-01-06 · Westmed - BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to…
FDA Device · Class II · 2021-01-06 · Becton Dickinson And - BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to…
FDA Device · Class II · 2021-01-06 · Becton Dickinson And - Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
FDA Device · Class II · 2021-01-06 · Boston Scientific - cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
FDA Device · Class II · 2021-01-06 · Roche Diagnostics Operations - REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter…
FDA Device · Class II · 2021-01-06 · Westmed - PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
FDA Device · Class II · 2021-01-06 · Smiths Medical Asd - Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only
FDA Device · Class II · 2021-01-06 · Medtronic Neurosurgery - Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic…
FDA Device · Class II · 2021-01-06 · Covidien - BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to t…
FDA Device · Class II · 2021-01-06 · Becton Dickinson And - Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BAS…
FDA Device · Class II · 2021-01-06 · Roi Cps - Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only
FDA Device · Class II · 2021-01-06 · Medtronic Neurosurgery - Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module
FDA Device · Class II · 2021-01-06 · Roche Diagnostics Operations - Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
FDA Device · Class II · 2021-01-06 · Boston Scientific - Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to c…
FDA Device · Class II · 2021-01-06 · Westmed - Product Code: K12T-02871, Revision A, Custom Procedure Kit, Embolization Kit Sterile EO, Rx Only, (01)00884450339121 For Angiography/angiop…
FDA Device · Class II · 2021-01-06 · Merit Medical Systems - BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to th…
FDA Device · Class II · 2021-01-06 · Becton Dickinson And - CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (t…
FDA Device · Class II · 2021-01-06 · Lidco - BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to th…
FDA Device · Class II · 2021-01-06 · Becton Dickinson And
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)