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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