RecallHawk

Medical Device Recalls

FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.

13,606 total recalls

Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decor

Stryker Corporation

Fusion Bioline Vascular Graft, Part number M00201503046B0

Maquet Cardiovascular, LLC

Artis Q.zen biplane, Model Number 10848355

Siemens Medical Solutions USA, Inc

ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

Siemens Healthcare Diagnostics, Inc.

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55

MEDLINE INDUSTRIES, LP - Northfield

NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

Epimed International

Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575

MEDLINE INDUSTRIES, LP - Northfield

GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cat

Randox Laboratories

BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respirat

Maquet Medical Systems USA

COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01,

Copan Italia

regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit

ROi CPS LLC

Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;

DAYE (ANNE'S DAY LTD)

STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695

MEDLINE INDUSTRIES, LP - Northfield

RadiaLux Lighted Retractor (Pink), REF: 50-101-1

Medtronic Navigation, Inc.

Baxter Preveleak Surgical Sealant, Product Codes: ADS201808

Baxter Healthcare Corporation

Philips VL13-5 Transducer.

Philips Ultrasound, Inc

CombiDiagnost R90 is multi-functional general R/F systems.

Philips Healthcare

GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-85

Wipro GE Healthcare Private Ltd.

HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults a

Hamilton Medical, Inc.

Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System

NovaSignal Corp.

GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic

GE Healthcare, LLC

Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;

Philips North America Llc

Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/

Siemens Medical Solutions USA, Inc

Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B

Philips Respironics, Inc.

IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with

Ion Beam Applications S.A.

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

Abiomed, Inc.

RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it

Smith & Nephew Medical, Ltd.

Sara Plus Active Floor Lift

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Stryker Sustainability Solutions

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