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Food & drugs

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

30-12-2020

This update to the February 2020 safety communication provides information on the final guidance, Product Labeling for Laparoscopic Power...

Product safety

Target Recalls Infant Rompers Due to Choking Hazard

30-12-2020

The snaps can break or detach from the rompers, posing a choking, laceration and pinching hazards to children.

Product safety

Target Recalls Infant-Toddler Girl’s One-Piece Rashguard Swimsuits Due to Choking Hazard

30-12-2020

The snaps can break or detach from the suits, posing choking and laceration hazards to children.

Food & drugs

2020 Safety Communications

29-12-2020

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and...

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Food & drugs

Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites

02-06-2018

Sanders announced today that it is recalling its 3.75oz Milk Chocolate Covered Fudge Mini Bites because they may contain undeclared almonds. People...

Food & drugs

SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits

01-06-2018

SDQ Trading Inc. of 651A Lexington Ave, Brooklyn, NY 11221 is recalling its 16.5 oz packages of Cheese Biscuits because they may contain undeclared...

Food & drugs

SunMed Holdings, LLC Issues a Nationwide Recall of STAT-Check and Medline Manual Resuscitator Bags

01-06-2018

On May 29, 2018, SunMed Holdings, LLC initiated a nationwide recall of 18,808 units of STAT-Check and Medline resuscitator bags which were...

Food & drugs

HeartWare HVAD System by Medtronic: Class I Recall - Due to Unintended Intermittent Electrical Disconnection between the Power

01-06-2018

Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure...

Food & drugs

STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings: Recall - Patient Port May Detach During Use

01-06-2018

The patient port retaining ring of the affected bags may not fully seat which may allow the patient port to detach during use.

Food & drugs

Abbott Implements Corrective Action for Heartmate 3 Heart Pump

31-05-2018

Abbott is communicating to physicians about a field corrective action related to the HeartMate 3™ Left Ventricular Assist Device (LVAD). Abbott...

Food & drugs

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

31-05-2018

The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.

Food & drugs

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays D

31-05-2018

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer...