32 results
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Sources: EU EUDAMED, US FDA
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Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Enforcement
Class II
·Terminated·Karl Storz Endoscopy·April 8, 2020
Karl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers: 1. 8403xx series, which includes: 8403AX, AXC, BX, BXC, DXC, EXC, GXC, HX, HXK, HXP, KXC, MXC 2. 8401xx series, which includes: 8401AX, AXC, BX, BXC, DXC, GXC, HX, HXP, KXC. Product Usage: Video Laryngoscopes are used to visualize the airways and vocal cords during endotracheal intubation and for the inspection and examination of the upper respiratory tract. Video Laryngoscopes are designed for transient use in invasive procedures through a body orifice.
FDA Recall
Terminated
·Karl Storz Endoscopy·Product code EQN·December 6, 2019
Safeway Sterile Preserved Saline Solution 12oz, Product SKU#321130-700707. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
FDA Recall
Terminated
·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010
Kroger Sterile Preserved Saline Solution 12oz, Product SKU#011110-385956. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
FDA Recall
Terminated
·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010
Publix Sterile Preserved Saline Solution 12oz, Product SKU#041415-003767. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
FDA Recall
Terminated
·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010
CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
FDA Recall
Terminated
·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010
Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. Sold under the following brand names: Family Dollar HomeBest HEB Meijer Food Lion health PRIDE Stop and Shop Super G sunmark Brite-Life Wegmans Our Family Healthy Generations GoodSense Winn Dixie Finast Western Family K C Pharmaceuticals
FDA Recall
Terminated
·K C Pharmaceuticals Inc·Product code LPN·October 4, 2004
Top Care Sterile Preserved Saline Solution 12oz, Product SKU#0036800-16040. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
FDA Recall
Terminated
·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010
Hannaford Sterile Preserved Saline Solution 12oz, Product SKU#041268-029297. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.
FDA Recall
Terminated
·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DXC·March 11, 2020
EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile R, Edwards Lifesciences LLC Irvine, CA***". The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
FDA Recall
Terminated
·Edwards Lifesciences Research Medical, Inc.·Product code DXC·September 24, 2009
Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.
FDA Recall
Terminated
·Zimmer Inc.·Product code HXC·November 7, 2008
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
FDA Recall
Terminated
·Sam Medical Products·Product code DXC·August 14, 2014
CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure
FDA Recall
Terminated
·Edwards Lifesciences Research Medical, Inc.·Product code DXC·November 26, 2008
Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code KAC·December 15, 2006
Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code DXC·May 5, 2010
DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
FDA Recall
Terminated
·DePuy Spine, Inc.·Product code HXC·July 24, 2012
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable compression of the puncture site with an inflatable bulb, and a check valve for easy inflation and deflation with a syringe. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.
FDA Recall
Terminated
·Merit Medical Systems, Inc.·Product code DXC·March 3, 2017
Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
FDA Recall
Terminated
·Biomet Spine, LLC·Product code HXC·March 12, 2015
IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude intra-aortic occlusion device occludes and vents the ascending aorta when the balloon is inflated.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DXC·May 14, 2019