Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,708 total recalls
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Texas Medical Technology Inc.
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Olympus Corporation of the Americas
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Des
Electro Medical Systems SA
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F
Medline Industries, LP
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. In
Baxter Healthcare Corporation
GEM Premier 5000 PAK; Part No. 00055407511.
Instrumentation Laboratory
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Civco Medical Instruments Co. Inc.
BD Pyxis Pro MedStation Main, REF: 1155-00
CareFusion 303, Inc.
Pain Tray Catalog Number: 9883
Busse Hospital Disposables, Inc.
SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
Philips North America
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and inter
Siemens Medical Solutions USA, Inc
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM
BioPro, Inc.
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are
Olympus Corporation of the Americas
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu
Howmedica Osteonics Corp.
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0C
Diasol, Inc
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Ventec Life Systems, Inc.
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
ROi CPS LLC
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Stryker Communications
Core Biopsy Tray Catalog Number: 8673R4
Busse Hospital Disposables, Inc.
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following mat
Magellan Diagnostics, Inc.
Ziehm Solo FD. Interventional fluoroscopic x-ray system
Orthoscan, Inc.
Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of t
Philips North America Llc
STERIS CORP Revital-Ox Resert Hydrogen Peroxide High-Level Disinfectant Revital-Ox RESERT RTU Liquid 4 Liter Container M
Mckesson Medical-Surgical Inc. Corporate Office
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Mobius Mobility LLC
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A
Steris Corporation
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, T
Baxter Healthcare Corporation
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Car
Medtronic Perfusion Systems
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH,
MEDLINE INDUSTRIES, LP - Northfield
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting
Olympus Corporation of the Americas
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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