130 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·August 10, 2010
HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
FDA Recall
Terminated
·Atrium Medical Corporation·Product code GBS·August 10, 2010
Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated Low Prime Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·May 3, 2011
Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.
FDA Recall
Terminated
·Medical Positioning Inc·Product code IXR·February 1, 2010
Rapid Response HUT (Head Up Tilt) Table. Model 1217. Powered electrophysiology tilt table with dual 2 way drop section. Table that can tilt -15 degree to 90 degree (Trendelenburg). Medical Positioning Incorporated. 800-593-3246. Used in clinical and hospital settings by trained radiologists.
FDA Recall
Terminated
·Medical Positioning Inc·Product code IXR·February 1, 2010
Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.
FDA Recall
Terminated
·Medical Positioning Inc·Product code IXR·February 1, 2010
Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.
FDA Recall
Terminated
·Hamilton Co·Product code JJE·September 26, 2011
VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·February 16, 2016
1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code DHA·February 18, 2016
GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZI·May 4, 2011
The product is a battery operated toothbrush. Spinbrush Pro Whitening Ex Soft battery operated toothbrushes UPC 76687800191.
FDA Recall
Terminated
·Proctor & Gamble Co·Product code JEQ·February 23, 2005
The product is a battery operated toothbrush. Spinbrush Pro Ex Soft battery operated toothbrushes UPC 76687800078
FDA Recall
Terminated
·Proctor & Gamble Co·Product code JEQ·February 23, 2005
Oral-B CrossAction PowerMAX Rechargeable Toothbrush, , Soft 4 Accent Colors: Blue, Pink, Green. Purple NDC 0-69055-83293-6
FDA Recall
Terminated
·Gillette Research Institute·Product code JEQ·October 27, 2004
Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also included in the recall, which is used by customers for ordering only . There is no labeling associated with this catalog number. This catalog number is used for ordering Cat. #4920 along with Cat. #MVS1011C-20g, Light Pipe (which is not under recall). These two products are packaged separately and are not bundled in any way. They are merely shipped at the same time. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQE·December 14, 2006
Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Model BL5110, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQE·January 8, 2010
Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQE·January 8, 2010
Bausch & Lomb Stellaris Premium AFS Phaco Pack, Model BL5120, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HQE·January 8, 2010
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQE·January 2, 2020
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DQE·January 2, 2020
25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
FDA Recall
Terminated
·Synergetics Inc·Product code HQE·August 11, 2016