FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 30 of 520
ABBOTT DIAGNOSTICS ARC T-UPTAKE ASSAY (100TST/BX) ABBDIA REAGENT.
Mckesson Medical-Surgical Inc. Corporate Office
Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (S…
C-RAD POSITIONING AB
HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.
Mckesson Medical-Surgical Inc. Corporate Office
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
C.R. Bard Inc
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professi…
Echopixel, Inc.
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Philips North America Llc
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Cook Incorporated
Product Name: Ingenia 3.0T CX; Model Number: 781271;
Philips North America Llc
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Centerline Biomedical Inc
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Philips North America Llc
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Philips North America Llc
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Cook Incorporated
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Advanced Bionics, LLC
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
C.R. Bard Inc
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew, Inc.
PhenoMATRIX
Copan WASP
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Philips North America Llc
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Philips North America Llc
Product Name: Ingenia 1.5T S; Model Number: 781347;
Philips North America Llc
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Philips North America Llc
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Philips North America Llc
Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;
Philips North America Llc
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Philips North America Llc
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Baxter Healthcare Corporation
Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
Philips North America Llc
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Ethicon Endo-Surgery Inc
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
C.R. Bard Inc
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Philips North America Llc
Intera 1.5T Master/Nova, Model Number: 781106;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Numed Inc
SmartPath to dStream for 3.0T, Model Number: 782145;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
MEDLINE INDUSTRIES, LP - Northfield
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 …
Beckman Coulter Inc.
FoundationOne Companion Diagnostic (F1CDx)
Foundation Medicine, Inc.
SmartPath to dStream for 1.5T, Model Number: 782146;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
AVID Medical, Inc.
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended …
Abbott Molecular, Inc.
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN M…
Cook Incorporated
Intera 1.0T Omni/Stellar, Model Number: 781102;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
AVID Medical, Inc.
Enterprise 1.5T, Model Number: 781145;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric s…
Richard Wolf GmbH
Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLi…
Vyaire Medical
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction…
Abbott Molecular, Inc.
Intera 1.5T Omni/Stellar, Model Number: 781104;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Intera 0.5T Standard, Model Number: 781101;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayT…
Klinika Mdical Gmb
Brand Name: Contour Product Name: Contour Gold Eyelid Weight Model/Catalog Number: LL3012 Product Description: Contour Gold Eyelid Weight, 1.2 gm …
Meddev Corp