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Recall Observatory FDA recall evidence

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Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 3424 of 3462

Product Firm Event Initiated
CUERNOS (CROISSANT) QTY: 90 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
TACOS DE PINA QTY: 120 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
EMPANADA PINA QTY: 100 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
TORTUGAS QTY: 60 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
CONCHA CHOCOLATE QTY: 90 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
TACOS DE MANZANA QTY: 120 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
CONCHA ROSA QTY: 90 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
CONCHA BLANCAS (VANILLA) QTY: 90 MEXICANTOWN BAKERY 313-894-2000 Mexicantown Wholesale Event 62055 May 08, 2012
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products MTI Precision Products LLC. Event 68570 May 07, 2012
V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only. Mindray DS USA, Inc. d.b.a. Mindray North America Event 62880 May 07, 2012
US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure Non-Invasive Monitoring Systems, Inc. Event 61868 May 07, 2012
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure Non-Invasive Monitoring Systems, Inc. Event 61868 May 07, 2012
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Civco Medical Instruments Inc Event 61793 May 07, 2012
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Philips Medical Systems (Cleveland) Inc Event 61866 May 07, 2012
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Civco Medical Instruments Inc Event 61793 May 07, 2012
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use. JK Products & Services, Inc Event 61855 May 07, 2012
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Civco Medical Instruments Inc Event 61793 May 07, 2012
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Civco Medical Instruments Inc Event 61793 May 07, 2012
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices Civco Medical Instruments Inc Event 61793 May 07, 2012
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, FAIR, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. Guthy-Renker LLC Event 72089 May 07, 2012
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, DARK, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. Guthy-Renker LLC Event 72089 May 07, 2012
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, TAN, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. Guthy-Renker LLC Event 72089 May 07, 2012
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, MEDIUM, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. Guthy-Renker LLC Event 72089 May 07, 2012
Rodan & Fields Proactiv Solution, Sheer Finish Compact Foundation, salicylic acid acne treatment, LIGHT, 7 g/0.25 OZ. Compacts, Over the Counter. Manufactured for Guthy-Renker Palm Desert, CA 92250. Guthy-Renker LLC Event 72089 May 07, 2012
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70. Endo Pharmaceuticals, Inc. Event 61791 May 07, 2012

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