Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 219 of 548
FDA Devices Moderate May 13, 2020
REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R,…
ICU Medical, Inc.
FDA Devices Moderate May 13, 2020
da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
Intuitive Surgical, Inc.
FDA Devices Moderate May 13, 2020
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to …
Intuitive Surgical, Inc.
FDA Devices Moderate May 13, 2020
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761…
Nobel Biocare Usa Llc
FDA Devices Moderate May 13, 2020
Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound syst…
Philips Ultrasound Inc
FDA Devices Moderate May 13, 2020
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Stryker Corporation
FDA Devices Low May 13, 2020
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including d…
Abbott Laboratories
FDA Devices Moderate May 13, 2020
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): prod…
Varian Medical Systems, Inc.
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair …
Maquet Cardiovascular, LLC
FDA Devices Low May 13, 2020
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diab…
Abbott Laboratories
FDA Devices Moderate May 13, 2020
3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates imp…
Trilliant Surgical, LLC
FDA Devices Moderate May 13, 2020
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pa…
Wright Medical Technology Inc
FDA Devices Moderate May 13, 2020
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
R82 A/S
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair …
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Prod…
Philips Ultrasound Inc
FDA Devices Moderate May 13, 2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement or repair …
Maquet Cardiovascular, LLC
FDA Devices Moderate May 13, 2020
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Int…
Epimed International
FDA Devices Moderate May 13, 2020
Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imagin…
Philips Ultrasound Inc
FDA Devices Moderate May 13, 2020
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Intr…
Epimed International
FDA Devices Moderate May 13, 2020
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
Delfi Medical Innovations, Inc.
FDA Devices Moderate May 13, 2020
Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - Produc…
Gentell, Inc
FDA Devices Moderate May 13, 2020
System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without …
Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 6, 2020
X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT…
WELCH ALLYN, INC/MORTARA
FDA Devices Moderate May 6, 2020
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemost…
Boston Scientific Corporation
FDA Devices Moderate May 6, 2020
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoro…
Philips North America, LLC
FDA Devices Moderate May 6, 2020
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Con…
WELCH ALLYN, INC/MORTARA
FDA Devices Moderate May 6, 2020
Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CBL 10WIRE I…
WELCH ALLYN, INC/MORTARA
FDA Devices Moderate May 6, 2020
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
FDA Devices Moderate May 6, 2020
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro …
Uromedica Inc.
FDA Devices Moderate May 6, 2020
Lunar iDXA bone densitometer
GE Healthcare, LLC
FDA Devices Moderate May 6, 2020
Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
GE Healthcare, LLC
FDA Devices Moderate May 6, 2020
Prismaflex System, Prismaflex Control Unit
Baxter Healthcare Corporation
FDA Devices Moderate May 6, 2020
Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil)…
Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate May 6, 2020
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Viewray, Inc.
FDA Devices Moderate May 6, 2020
Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs. Sold under the followin…
WELCH ALLYN, INC/MORTARA
FDA Devices Moderate May 6, 2020
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Merit Medical Systems, Inc.
FDA Devices Moderate May 6, 2020
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is i…
U&I CORP.
FDA Devices Moderate May 6, 2020
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Elekta Inc
FDA Devices Moderate May 6, 2020
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Boston Scientific Corporation
FDA Devices Moderate May 6, 2020
Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Produc…
Stryker Sustainability Solutions
FDA Devices Moderate May 6, 2020
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 6, 2020
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) …
Becton Dickinson & Company
FDA Devices Moderate May 6, 2020
T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data …
WELCH ALLYN, INC/MORTARA
FDA Devices Moderate May 6, 2020
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is…
Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
FDA Devices Moderate May 6, 2020
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used …
Obalon Therapeutics Inc
FDA Devices Critical May 6, 2020
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Vascular Solutions, Inc.
FDA Devices Moderate May 6, 2020
CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
Avanos Medical, Inc.
FDA Devices Moderate May 6, 2020
Q-Tel. The Q-Tel RMS system is a computer-based cardiac and pulmonary rehabilitation data acquisition and editing system.
WELCH ALLYN, INC/MORTARA
FDA Devices Moderate May 6, 2020
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Philips North America, LLC
FDA Devices Moderate May 6, 2020
SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System…
Beckman Coulter Inc.