Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 138 of 548
FDA Devices Moderate Nov 9, 2022
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 9, 2022
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 9, 2022
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients hand, wrist, …
Baxter Healthcare Corporation
FDA Devices Moderate Nov 9, 2022
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimula…
Johnson & Johnson Surgical Vision, Inc.
FDA Devices Moderate Nov 9, 2022
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients hea…
Baxter Healthcare Corporation
FDA Devices Moderate Nov 9, 2022
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arte…
Edwards Lifesciences, LLC
FDA Devices Moderate Nov 9, 2022
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 9, 2022
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 9, 2022
CritiCool, thermoregulation device
Belmont Instrument Corporation
FDA Devices Critical Nov 9, 2022
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Baxter Healthcare Corporation
FDA Devices Moderate Nov 9, 2022
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 9, 2022
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Boston Scientific Corporation
FDA Devices Moderate Nov 9, 2022
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
MICROVENTION INC.
FDA Devices Moderate Nov 9, 2022
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 9, 2022
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 9, 2022
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Boston Scientific Corporation
FDA Devices Moderate Nov 9, 2022
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 2, 2022
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
Intuitive Surgical, Inc.
FDA Devices Moderate Nov 2, 2022
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Datascope Corporation
FDA Devices Moderate Nov 2, 2022
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Nov 2, 2022
ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a colostomy or ileo…
ConvaTec, Inc
FDA Devices Moderate Nov 2, 2022
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or…
ConvaTec, Inc
FDA Devices Moderate Nov 2, 2022
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Encore Medical, LP
FDA Devices Moderate Nov 2, 2022
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, C…
Merit Medical Systems, Inc.
FDA Devices Moderate Nov 2, 2022
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Wright Medical Technology, Inc.
FDA Devices Moderate Nov 2, 2022
ARIES SARS-CoV-2 Assay, REF: 50-10047
Luminex Corporation
FDA Devices Moderate Nov 2, 2022
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either perip…
Angiodynamics, Inc.
FDA Devices Moderate Nov 2, 2022
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or il…
ConvaTec, Inc
FDA Devices Moderate Nov 2, 2022
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Wright Medical Technology, Inc.
FDA Devices Low Nov 2, 2022
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended …
LumiraDx
FDA Devices Moderate Nov 2, 2022
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Encore Medical, LP
FDA Devices Moderate Oct 26, 2022
Medicina Oral Tip Syringe 0.5ml Code: OT005
Medicina Uk Ltd
FDA Devices Moderate Oct 26, 2022
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
Medicina Uk Ltd
FDA Devices Moderate Oct 26, 2022
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN): 10464340 Catalog Number: K3…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 26, 2022
Medicina Oral Tip Syringe 2.5ml Code: OT25
Medicina Uk Ltd
FDA Devices Moderate Oct 26, 2022
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 access t…
ARROW INTERNATIONAL Inc.
FDA Devices Moderate Oct 26, 2022
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
Medicina Uk Ltd
FDA Devices Moderate Oct 26, 2022
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Oct 26, 2022
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
SIEMENS HEALTHCARE DIAGNOSTICS INC
FDA Devices Moderate Oct 26, 2022
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
SIEMENS HEALTHCARE DIAGNOSTICS INC
FDA Devices Critical Oct 26, 2022
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
TELEFLEX LLC
FDA Devices Moderate Oct 26, 2022
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery Sys…
Abbott Vascular
FDA Devices Moderate Oct 26, 2022
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Oct 26, 2022
Medicina Reusable Oral syringe 5ml Code: OTH05
Medicina Uk Ltd
FDA Devices Critical Oct 26, 2022
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter…
TELEFLEX LLC
FDA Devices Moderate Oct 26, 2022
Medicina Oral Tip Syringe 1ml Code: OT01
Medicina Uk Ltd
FDA Devices Critical Oct 26, 2022
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing syste…
TELEFLEX LLC
FDA Devices Moderate Oct 26, 2022
Medicina Reusable Oral syringe 2.5ml Code: OTH25
Medicina Uk Ltd
FDA Devices Moderate Oct 26, 2022
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Synthes (USA) Products LLC
FDA Devices Moderate Oct 26, 2022
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory se…
Roche Molecular Systems, Inc.