Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,633 total recalls
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosti
Philips North America Llc
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Heartware, Inc.
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
Biomerieux Inc
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Medtronic Perfusion Systems
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12M
Baxter Healthcare Corporation
Vasc. Open CVOR SJH, REF SJVO56B
American Contract Systems, Inc.
Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi,
Dollar Tree Distribution, Inc.
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accessories (simple, powere
SURGIFY MEDICAL OY
Thermalon Back Wrap, Item Number 24312
Bruder Healthcare Company, LLC
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version
Medartis AG
LAPAROSCOPIC GYN. Medical convenience kit.
AVID Medical, Inc.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number
Medline Industries, LP
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Zimmer, Inc.
Oxylog 3000 Plus emergency and transport ventilator
Draeger Medical, Inc.
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.
DIXI MEDICAL USA
Philips Respironics V60 Ventilator Part Number 1053617
Respironics California, LLC
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Baxter Healthcare Corporation
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080
TELEFLEX LLC
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
Cardinal Health 200, LLC
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567
Randox Laboratories Ltd.
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K16
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
CooperVision Inc.
Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number
Medline Industries, LP
Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281
MEDLINE INDUSTRIES, LP - Northfield
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer al
Abbott Laboratories
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Smith & Nephew, Inc.
NaviCare Nurse Call/Voalte Nurse Call
Baxter Healthcare Corporation
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12
Merge Healthcare, Inc.
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187
ASP Global, LLC. dba Anatomy Supply Partners, LLC.
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