FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgica…
FDA Device · Class III · 2020-05-27 · Immersivetouch - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - STEALTH SPRING CLIP 6mm latis (3/4 Force)
FDA Device · Class II · 2020-05-27 · Applied Medical Resources - Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all qu…
FDA Device · Class II · 2020-05-27 · Cardinal Health - Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthS…
FDA Device · Class I · 2020-05-27 · Medtronic Navigation - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from ano…
FDA Device · Class II · 2020-05-27 · Cardinal Health - STEALTH SPRING CLIP 6mm latis (1/2 Force)
FDA Device · Class II · 2020-05-27 · Applied Medical Resources - BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - STEALTH SPRING CLIP 6mm latis (1/4 Force)
FDA Device · Class II · 2020-05-27 · Applied Medical Resources - BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits…
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoC…
FDA Device · Class II · 2020-05-27 · Capso Vision - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90121, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - The Optilite Clinical Chemistry Analyzer
FDA Device · Class II · 2020-05-27 · The Binding Site Group - NelDerm Hydrogel Dressing (Dressing: 6 x 6
FDA Device · Class II · 2020-05-27 · Nelson Innovaions - Renuvion/ J-Plasma Precise Handpiece
FDA Device · Class II · 2020-05-27 · Bovie Medical - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90115, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Descriptio…
FDA Device · Class II · 2020-05-27 · Medline Industries - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - NRG RF Transseptal Kit
FDA Device · Class II · 2020-05-27 · Baylis Medical - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90179, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits…
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90135, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 left, Sterile, Catalog # 504-02-68F-L, UDI (01)07613327012521(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - Frames Direct Prescription Spectacle Lenses included in the frame brands
FDA Device · Class II · 2020-05-27 · Frames Direct - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip…
FDA Device · Class III · 2020-05-27 · Pega Medical - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device…
FDA Device · Class II · 2020-05-27 · Medline Industries - BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90157, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system
FDA Device · Class II · 2020-05-27 · Clinical Innovations - BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gra…
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90137, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device…
FDA Device · Class II · 2020-05-27 · Medline Industries - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90111, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - HeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the Philips HeartStart MRx Monitorl/Defibrillator - Produc…
FDA Device · Class II · 2020-05-27 · Philips North America - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - TorFlex Transseptal Guiding Sheath
FDA Device · Class II · 2020-05-27 · Baylis Medical - Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personne…
FDA Device · Class II · 2020-05-27 · Philips North America - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular devic…
FDA Device · Class II · 2020-05-27 · Medline Industries - AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of…
FDA Device · Class II · 2020-05-27 · Advanced Bionics - Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the de…
FDA Device · Class II · 2020-05-27 · W L Gore And Associates - DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Prod…
FDA Device · Class II · 2020-05-27 · Merit Medical Systems - Renuvion/ J-Plasma Precise Open Handpiece
FDA Device · Class II · 2020-05-27 · Bovie Medical - BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organ…
FDA Device · Class II · 2020-05-27 · Boston Scientific - Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte…
FDA Device · Class II · 2020-05-20 · Icu Medical - Analyte specific reagent
FDA Device · Class II · 2020-05-20 · Becton Dickinson And Bd Biosciences - Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for…
FDA Device · Class II · 2020-05-20 · Covidien - Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction…
FDA Device · Class II · 2020-05-20 · Merit Medical Systems - TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory s…
FDA Device · Class II · 2020-05-20 · Cardiac Assist - BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Ven…
FDA Device · Class II · 2020-05-20 · Bard Peripheral Vascular - TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal…
FDA Device · Class II · 2020-05-20 · Cardiac Assist - Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL…
FDA Device · Class II · 2020-05-20 · Covidien - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The…
FDA Device · Class II · 2020-05-20 · Ortho Clinical Diagnostics - Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer…
FDA Device · Class II · 2020-05-20 · Covidien - Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for…
FDA Device · Class II · 2020-05-20 · Covidien - TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal cir…
FDA Device · Class II · 2020-05-20 · Cardiac Assist - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit
FDA Device · Class II · 2020-05-20 · Access Scientific - iQ200 Series Urine Microscopy Analyzer- All part numbers
FDA Device · Class II · 2020-05-20 · Beckman Coulter - Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide…
FDA Device · Class II · 2020-05-20 · Siemens Medical Solutions Usa - Oxymetry Cable, Rxonly
FDA Device · Class II · 2020-05-20 · Edwards Lifesciences - Insufflation tubing to be used with varies insufflator units
FDA Device · Class III · 2020-05-20 · Karl Storz Endoscopy - Sterile Oxymetry Oligon Catheter Kit
FDA Device · Class II · 2020-05-20 · Edwards Lifesciences - Quickie/Zippie powered wheelchair
FDA Device · Class II · 2020-05-20 · Sunrise Medical Us - Stryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a powered wheeled stretcher that is intended to suppor…
FDA Device · Class II · 2020-05-20 · Stryker Medical Division - Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre…
FDA Device · Class II · 2020-05-20 · Covidien - Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL…
FDA Device · Class II · 2020-05-20 · Covidien - Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte…
FDA Device · Class II · 2020-05-20 · Icu Medical - Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Tempe…
FDA Device · Class II · 2020-05-20 · Covidien - Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainles…
FDA Device · Class II · 2020-05-20 · Cook - Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide…
FDA Device · Class II · 2020-05-20 · Siemens Medical Solutions Usa - VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
FDA Device · Class II · 2020-05-20 · Medtronic Sofamor Danek Usa - BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is…
FDA Device · Class II · 2020-05-20 · Access Scientific - SWIN 2017 database, Model YSW4000
FDA Device · Class II · 2020-05-20 · Remel - EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The E…
FDA Device · Class II · 2020-05-20 · Encore Medical - TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circu…
FDA Device · Class II · 2020-05-20 · Cardiac Assist - Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary arte…
FDA Device · Class II · 2020-05-20 · Icu Medical
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