RecallHawk

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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