Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,600 total recalls
Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination t
Oakworks Inc
Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009
Medtronic Perfusion Systems
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Fresenius Medical Care Holdings, Inc.
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224
CareFusion 303, Inc.
VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
bioMerieux, Inc.
X8-2t Transducer Probe
Philips Ultrasound, Inc
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: Th
Hitachi America, Ltd., Particle Therapy Division
DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
DeRoyal Industries Inc
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The
Kirwan Surgical Products, LLC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
UIH Technologies LLC
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
INSPIREMD Inc
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
Acumed LLC
GEM Premier 5000; Part No. 00055430011.
Instrumentation Laboratory
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Siemens Medical Solutions USA, Inc.
Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" St
C.R. Bard Inc
Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set
Aesculap Implant Systems LLC
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TRAY-LF DYNJ54603B
Medline Industries, LP
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
Caire, Inc.
Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-02
AVID Medical, Inc.
medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Smiths Medical ASD, Inc.
C9-3io Transducer Probe
Philips Ultrasound, Inc
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
MEDLINE INDUSTRIES, LP - Northfield
Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
MEDLINE INDUSTRIES, LP - Northfield
Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Conne
Silex Medical, LLC
MediBeads Neck Wrap, Item Number 34320
Bruder Healthcare Company, LLC
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
BioPro, Inc.
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)
Maquet Cardiovascular, LLC
Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
Biomet, Inc.
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X
Micro-X Ltd.
Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
Zimmer, Inc.
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