Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBI
Baxter Healthcare Corporation
Luminos dRF Max (VE10, VF10, VF11)
Siemens Medical Solutions USA, Inc
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the
Angiodynamics, Inc.
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmo
St. Jude Medical
AirFit F30 Full Face Mask and User Guide
ResMed Ltd.
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501,
LEICA BIOSYSTEMS NUSSLOCH GMBH
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation
RAYSEARCH LABORATORIES AB
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in
Changchun Wancheng Bio-Electron Co., Ltd.
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0
RAYSEARCH LABORATORIES AB
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Philips North America Llc
Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320
Avanos Medical, Inc.
Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K1419
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
Busse Hospital Disposables, Inc.
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Illumina, Inc.
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000
Abbott Laboratories
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
GE Healthcare, LLC
Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000
ARROW INTERNATIONAL, LLC
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The
Hitachi America, Ltd., Particle Therapy Division
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer
Baxter Healthcare Corporation
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
Busse Hospital Disposables, Inc.
Philips MR 7700 System, Model Number 782120
Philips North America Llc
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosi
Landauer
Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716
Medline Industries, LP
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2
GE Healthcare
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Nu
Olympus Corporation of the Americas
RayStation 7.0.0.19. Radiation Therapy Treatment Planning System.
RAYSEARCH LABORATORIES AB
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Flux Technology Inc.
CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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