Food & drugs

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from So

28-10-2016

Loose power connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures.

Back to Nature Issues a Product Recall and Allergy Alert for Chocolate Chunk Cookies, Mini Chocolate Chunk Cookies and Chocolat

28-10-2016

Back to Nature Foods, LLC is voluntarily recalling four (4) products because those products contain chocolate purchased from a third party supplier which was found to contain undeclared Milk that is not listed as an ingredient on the label.

Stewart's Shops Issues Allergy Alert On Undeclared Milk In Sportade Fruit Punch

27-10-2016

Saratoga Springs, NY-Stewart's Shops Corp. is recalling units of Stewart's Sportade Fruit Punch Isotonic Beverage 20 fluid oz. because they may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening...

TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortali

26-10-2016

The most recent post-approval study results assessing post-market performance is available.

Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

25-10-2016

New Warning and updated Abuse and Dependence sections of labeling, including new safety information from published literature and case reports.

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues

24-10-2016

Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.

Brownwood Farms Issues Allergy Alert On Undeclared Milk In Fruit Preserves And Fruit Butter Products

21-10-2016

Brownwood Farms of Williamsburg, MI is recalling approximately 260,000 total units of the listed products, because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening...

Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use

20-10-2016

Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention.

Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients

20-10-2016

The FDA is concerned that health care providers may be unaware of the risks associated with these devices.

Yoma Myanmar Tea Co. Issues Allergy Alert on Undeclared Peanuts in Yoma Myanmar Tea Salad Snack

18-10-2016

Yoma Myanmar Tea Co. of Allston, MA is voluntarily recalling the Yoma Myanmar brand "Tea Salad Snack" in Regular and Spicy, 7 oz., because the products may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or...

Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

18-10-2016

PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.

Medtronic Announces Voluntary Recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic G

18-10-2016

This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter...

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Food & drugs

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from So

Back to Nature Issues a Product Recall and Allergy Alert for Chocolate Chunk Cookies, Mini Chocolate Chunk Cookies and Chocolat

Stewart's Shops Issues Allergy Alert On Undeclared Milk In Sportade Fruit Punch

TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortali

Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues

Brownwood Farms Issues Allergy Alert On Undeclared Milk In Fruit Preserves And Fruit Butter Products

Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use

Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients

Yoma Myanmar Tea Co. Issues Allergy Alert on Undeclared Peanuts in Yoma Myanmar Tea Salad Snack

Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Medtronic Announces Voluntary Recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic G

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UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

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