FDA (Device enforcement)

11,102 recalls · page 96 of 112

• Healix Knotless ADV BR 4.75 Suture Anchor2019-11-04
• Healix Knotless ADV BR 5.5 Suture Anchor2019-11-04
• Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable2019-11-04
• iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis profile, including urine2019-10-28
• Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 4756602019-10-25
• Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 4756652019-10-25
• BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.2019-10-25
• Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 42019-10-24
• Guidezilla II Guide Extension Catheter Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493933515060, 6F; 2. REF/Catalog No H7493933515070, 7F.2019-10-24
• NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H7493927608400, NC EMERGE MR OUS 4.00MM2019-10-24
• Rebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chromium (PtCr) Alloy stent pre-mounted on a Monorail Catheter.2019-10-24
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.2019-10-21
• Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma2019-10-21
• MicroScan WalkAway-40 plus Instrument REF B1018-2832019-10-21
• MicroScan WalkAway-96 plus Instrument REF B1018-2842019-10-21
• DxM 1040 MicroScan WalkAway Instrument REF B1018-4402019-10-21
• DxM 1096 MicroScan WalkAway Instrument REF B1018-4962019-10-21
• MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R2019-10-21
• MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R2019-10-21
• CapsoCAM Plus, UDI: 008677700002092019-10-18
• Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.2019-10-14
• Radiofrequency Grounding Pad, REF RF-DGP-L2019-10-14
• Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens.2019-10-11
• Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.2019-10-09
• Prismaflex Control Unit, software versions below 7.212019-10-04
• Prismaflex Control Unit, software versions below 7.212019-10-04
• Prismaflex Control Unit, software versions below 7.212019-10-04
• Prismaflex Control Unit, software versions below 7.212019-10-04
• Prismaflex Control Unit, software versions below 7.212019-10-04
• Randox Liquid Cardiac Controls Catalogue Number CQ50512019-10-04