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.
- MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single…
FDA Device · Class II · 2021-08-18 · Merit Medical Systems - HeartWare HVAD Pump Implant Kit, REF 1103
FDA Device · Class I · 2021-08-18 · Heartware - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
FDA Device · Class II · 2021-08-18 · Biomet - S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002,…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended f…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
FDA Device · Class II · 2021-08-18 · Biomet - TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Numb…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Device · Class I · 2021-08-18 · Heartware - MYLA software
FDA Device · Class II · 2021-08-18 · Biomerieux - HeartWare HVAD Pump Implant Kit, REF 1104
FDA Device · Class I · 2021-08-18 · Heartware - smith&nephew BHR SQUARE HEADED NAIL, REF CATALOG NUMBER 999908
FDA Device · Class II · 2021-08-18 · Smith And Nephew Orthopaedics Aurora - Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
FDA Device · Class II · 2021-08-18 · Biomet - IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Simpleware ScanIP medical software
FDA Device · Class II · 2021-08-18 · Simpleware Product Group Synopsys Northern Europe - Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setti…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
FDA Device · Class II · 2021-08-18 · Biomet - Dose IQ Safety Software used with Spectrum IQ Infusion Pump
FDA Device · Class I · 2021-08-18 · Baxter Healthcare - Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
FDA Device · Class II · 2021-08-18 · Biomet - Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile E…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
FDA Device · Class II · 2021-08-18 · Biomet - HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Device · Class I · 2021-08-18 · Heartware - Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Number…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Cannulated graduated drill bit 1.9 mm diameter, with AO QC system, REF: INS-114 for use in orthopedic surgery
FDA Device · Class II · 2021-08-18 · Neosteo - GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489…
FDA Device · Class II · 2021-08-18 · Merit Medical Systems - Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710,…
FDA Device · Class II · 2021-08-18 · Stryker Medical Division - Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020)
FDA Device · Class II · 2021-08-18 · Medline Industries - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
FDA Device · Class II · 2021-08-18 · Biomet - Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number: 11-301322
FDA Device · Class II · 2021-08-18 · Biomet - FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
FDA Device · Class II · 2021-08-18 · Biofire Diagnostics - Alinity s System REF 06P16-01
FDA Device · Class II · 2021-08-18 · Abbott Laboratories - Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids
FDA Device · Class I · 2021-08-18 · Baxter Healthcare - Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03
FDA Device · Class II · 2021-08-18 · Exactech - Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
FDA Device · Class II · 2021-08-18 · Cordis - Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
FDA Device · Class II · 2021-08-18 · Biomet - Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommen…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
FDA Device · Class II · 2021-08-18 · Medtronic Neuromodulation - Regard NEWBORN KIT, LD00201j, Item Number: 830016010
FDA Device · Class II · 2021-08-11 · Roi Cps - Sharesource Connectivity Platform for Use with the Amia Automated PD System
FDA Device · Class II · 2021-08-11 · Baxter Healthcare - Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent
FDA Device · Class III · 2021-08-11 · Stanbio Laboratory - Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - Regard NEWBORN KIT, LD00201M, Item Number: 830016013
FDA Device · Class II · 2021-08-11 · Roi Cps - REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
FDA Device · Class II · 2021-08-11 · Abbott Laboratories - Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast
FDA Device · Class II · 2021-08-11 · Stryker - TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - Regard NEWBORN KIT, LD00201K, Item Number: 830016011
FDA Device · Class II · 2021-08-11 · Roi Cps - Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent
FDA Device · Class III · 2021-08-11 · Stanbio Laboratory - GlideScope Go Monitors
FDA Device · Class III · 2021-08-11 · Verathon - REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
FDA Device · Class II · 2021-08-11 · Abbott Laboratories - Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent
FDA Device · Class III · 2021-08-11 · Stanbio Laboratory - Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent
FDA Device · Class III · 2021-08-11 · Stanbio Laboratory - 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, I…
FDA Device · Class II · 2021-08-11 · Abbott Laboratories - Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast
FDA Device · Class II · 2021-08-11 · Stryker - Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument
FDA Device · Class II · 2021-08-11 · Straumann Usa - Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
FDA Device · Class II · 2021-08-11 · Abbott Laboratories - 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
FDA Device · Class II · 2021-08-11 · Tenderneeds Fertility - Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent
FDA Device · Class III · 2021-08-11 · Stanbio Laboratory - Kaguya Automated Peritoneal Dialysis System
FDA Device · Class II · 2021-08-11 · Baxter Healthcare - Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person…
FDA Device · Class II · 2021-08-04 · Sunrise Medical Us - Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Deli…
FDA Device · Class II · 2021-08-04 · Hill Rom - Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no
FDA Device · Class II · 2021-08-04 · Innovative Tomography Product - CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
FDA Device · Class II · 2021-08-04 · Cytocell - CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, an…
FDA Device · Class II · 2021-08-04 · Medtronic Vascular - Infusomat Space Volumetric Pump Administration Set, Product Code 490100
FDA Device · Class II · 2021-08-04 · B Braun Medical - OxyMask O2 Adult REF OM-1125-14
FDA Device · Class II · 2021-08-04 · Southmedic - AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016
FDA Device · Class I · 2021-08-04 · Eight Medical International Bv - Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
FDA Device · Class II · 2021-08-04 · Medtronic Neuromodulation - Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat inf…
FDA Device · Class II · 2021-08-04 · Medtronic Vascular - CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - CARESCAPE PDM-Masimo SpO2. Physiological data monitor
FDA Device · Class II · 2021-08-04 · Ge Healthcare - Proteus 235-Proton Therapy System
FDA Device · Class II · 2021-08-04 · Ion Beam Applications - Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers…
FDA Device · Class II · 2021-08-04 · Maquet Medical Systems Usa - ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
FDA Device · Class II · 2021-08-04 · Remel - FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional de…
FDA Device · Class II · 2021-08-04 · Merit Medical Systems - SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no
FDA Device · Class II · 2021-08-04 · Innovative Tomography Product - MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision - RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model…
FDA Device · Class II · 2021-08-04 · Raysearch Laboratories Ab - OEC Elite mobile C-arm - Product Usage: intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional too…
FDA Device · Class II · 2021-08-04 · Ge Oec Medical Systems - Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person…
FDA Device · Class II · 2021-08-04 · Sunrise Medical Us - OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile - Product Usage: designed to provide fluoroscopic and digital spot imag…
FDA Device · Class II · 2021-08-04 · Ge Oec Medical Systems
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