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.
- THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping…
FDA Device · Class II · 2022-11-09 · Johnson And Johnson Surgical Vision - MEDLINE CVC BARRIER KIT, REF DYNJ80485
FDA Device · Class II · 2022-11-09 · Medline Industries Northfield - BD Trucount Tubes (Cat
FDA Device · Class II · 2022-11-09 · Becton Dickinson And Bd Biosciences - EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System
FDA Device · Class II · 2022-11-09 · Boston Scientific - MEDLINE DENTAL PACK, REF DYNJ66983
FDA Device · Class II · 2022-11-09 · Medline Industries Northfield - Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002
FDA Device · Class II · 2022-11-09 · Baxter Healthcare - BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat
FDA Device · Class II · 2022-11-09 · Becton Dickinson And Bd Biosciences - MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures
FDA Device · Class II · 2022-11-09 · Medline Industries Northfield - Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev
FDA Device · Class I · 2022-11-09 · Baxter Healthcare - CritiCool, thermoregulation device
FDA Device · Class II · 2022-11-09 · Belmont Instrument - BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures
FDA Device · Class II · 2022-11-09 · Medline Industries Northfield - STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures…
FDA Device · Class II · 2022-11-09 · Ethicon - MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures
FDA Device · Class II · 2022-11-09 · Medline Industries Northfield - Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
FDA Device · Class II · 2022-11-09 · Edwards Lifesciences - Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101
FDA Device · Class II · 2022-11-09 · Baxter Healthcare - BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures
FDA Device · Class II · 2022-11-09 · Medline Industries Northfield - Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
FDA Device · Class I · 2022-11-09 · Baxter Healthcare - BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures
FDA Device · Class II · 2022-11-09 · Medline Industries Northfield - Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104
FDA Device · Class II · 2022-11-09 · Baxter Healthcare - Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized…
FDA Device · Class II · 2022-11-09 · Rebiscan - Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103
FDA Device · Class II · 2022-11-09 · Baxter Healthcare - Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table
FDA Device · Class II · 2022-11-09 · Baxter Healthcare - BD Trucount Tubes (Cat
FDA Device · Class II · 2022-11-09 · Becton Dickinson And Bd Biosciences - EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component
FDA Device · Class II · 2022-11-02 · Encore Medical - ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400599
FDA Device · Class II · 2022-11-02 · Convatec - da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System…
FDA Device · Class II · 2022-11-02 · Intuitive Surgical - Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray
FDA Device · Class II · 2022-11-02 · Angiodynamics - Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
FDA Device · Class II · 2022-11-02 · Wright Medical Technology - MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
FDA Device · Class II · 2022-11-02 · Medline Industries Northfield - LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are int…
FDA Device · Class III · 2022-11-02 · Lumiradx - CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA141…
FDA Device · Class II · 2022-11-02 · Merit Medical Systems - EMPOWER 3D Knee Tibial Insert, REF: 341-14-708
FDA Device · Class II · 2022-11-02 · Encore Medical - ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975
FDA Device · Class II · 2022-11-02 · Convatec - ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598
FDA Device · Class II · 2022-11-02 · Convatec - MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
FDA Device · Class II · 2022-11-02 · Medline Industries Northfield - ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976
FDA Device · Class II · 2022-11-02 · Convatec - ARIES SARS-CoV-2 Assay, REF: 50-10047
FDA Device · Class II · 2022-11-02 · Luminex - Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
FDA Device · Class II · 2022-11-02 · Wright Medical Technology - MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
FDA Device · Class II · 2022-11-02 · Medline Industries Northfield - GORE CARDIOFORM ASD Occluder. cardiovascular implant
FDA Device · Class II · 2022-11-02 · W L Gore And Associates - MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
FDA Device · Class II · 2022-11-02 · Medline Industries Northfield - MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
FDA Device · Class II · 2022-11-02 · Medline Industries Northfield - LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter
FDA Device · Class II · 2022-11-02 · Datascope - CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA…
FDA Device · Class II · 2022-11-02 · Merit Medical Systems - AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR
FDA Device · Class II · 2022-11-02 · Zoll Circulation - ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
FDA Device · Class II · 2022-11-02 · Siemens Medical Solutions Usa - BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001
FDA Device · Class II · 2022-10-26 · Becton Dickinson And - Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
FDA Device · Class II · 2022-10-26 · Medicina Uk - Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
FDA Device · Class II · 2022-10-26 · Medicina Uk - ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Exten…
FDA Device · Class II · 2022-10-26 · B Braun Medical - Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10
FDA Device · Class II · 2022-10-26 · Balt Usa - Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT R…
FDA Device · Class II · 2022-10-26 · Abbott Vascular - CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
FDA Device · Class II · 2022-10-26 · Medline Industries Northfield - N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
FDA Device · Class II · 2022-10-26 · Siemens Healthcare Diagnostics - Medicina Reusable Oral syringe 1ml Code: OTH01
FDA Device · Class II · 2022-10-26 · Medicina Uk - DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
FDA Device · Class II · 2022-10-26 · Synthes Usa Products - CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton
FDA Device · Class II · 2022-10-26 · B Braun Medical - Medicina Oral Tip Syringe 2.5ml Code: OT25
FDA Device · Class II · 2022-10-26 · Medicina Uk - Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only
FDA Device · Class I · 2022-10-26 · Teleflex - Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only
FDA Device · Class I · 2022-10-26 · Teleflex - Medicina Reusable Oral syringe 2.5ml Code: OTH25
FDA Device · Class II · 2022-10-26 · Medicina Uk - Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only
FDA Device · Class I · 2022-10-26 · Teleflex - N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
FDA Device · Class II · 2022-10-26 · Siemens Healthcare Diagnostics - Medicina Oral Tip Syringe 0.5ml Code: OT005
FDA Device · Class II · 2022-10-26 · Medicina Uk - Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Num…
FDA Device · Class II · 2022-10-26 · Siemens Healthcare Diagnostics - Filter + Catheter Mount, REF 191667-000100, OUS only
FDA Device · Class I · 2022-10-26 · Teleflex - ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral…
FDA Device · Class II · 2022-10-26 · Arrow International - Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Deli…
FDA Device · Class II · 2022-10-26 · Abbott Vascular - SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10
FDA Device · Class II · 2022-10-26 · Synthes Usa Products - Medicina Reusable Oral syringe 5ml Code: OTH05
FDA Device · Class II · 2022-10-26 · Medicina Uk - cobas 5800 instrument, Material No. 08707464001
FDA Device · Class II · 2022-10-26 · Roche Molecular Systems - Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
FDA Device · Class II · 2022-10-26 · Siemens Healthcare Diagnostics - SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
FDA Device · Class II · 2022-10-26 · Synthes Usa Products - Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Deli…
FDA Device · Class II · 2022-10-26 · Abbott Vascular - Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only
FDA Device · Class I · 2022-10-26 · Teleflex - Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
FDA Device · Class II · 2022-10-26 · Intersurgical - Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
FDA Device · Class II · 2022-10-26 · Siemens Healthcare Diagnostics - SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
FDA Device · Class II · 2022-10-26 · Synthes Usa Products - Medicina Oral Tip Syringe 1ml Code: OT01
FDA Device · Class II · 2022-10-26 · Medicina Uk - Iso-Gard Filter S, REF : a) 19211, OUS only
FDA Device · Class I · 2022-10-26 · Teleflex - Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton
FDA Device · Class II · 2022-10-26 · B Braun Medical - Hobbs Medical Polypectomy Snare Catalog Number: 4564
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Scope Introducer Catalog Number: 4650
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Retrieval Forceps Catalog Number: 5018
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Positron Emission Tomography and Computed Tomography System, Model: uMI 550
FDA Device · Class II · 2022-10-19 · Shanghai United Imaging Healthcare - Hobbs Biliary Pigtail Stent Kits Catalog Number: 6108
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6534
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6533
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6548
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Berkeley VC-10 Vacuum Curettage System, Model No. VC-10
FDA Device · Class II · 2022-10-19 · Olympus - Freeman Pancreatic Flexi-Stent Catalog Number: 6582
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Hobbs Helical Retrieval Basket Catalog Number: 4822
FDA Device · Class II · 2022-10-19 · Hobbs Medical - VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit
FDA Device · Class II · 2022-10-19 · Medline Industries Northfield - Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104
FDA Device · Class II · 2022-10-19 · Hobbs Medical - Freeman Pancreatic Flexi-Stent Catalog Number: 6566
FDA Device · Class II · 2022-10-19 · Hobbs Medical
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