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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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Product safety

Polaris Recalls RZR XP 4 Turbo Recreational Off-Highway Vehicles Due to Fire Hazard (Recall Alert)

21-12-2017

The return fuel line can be improperly secured which can cause fuel to leak, posing a fire hazard.

Food & drugs

Long-Acting Beta agonists (LABAs) and Inhaled Corticosteroids (ICS): Drug Safety Communication - Boxed Warning About Asthma-Rel

21-12-2017

FDA review of clinical safety trials shows that treating asthma with LABAs in combination with ICS does not result in significantly more serious...

Food & drugs

Pantoprazole Sodium for Injection 40 Mg Per Vial: Recall - Presence of Glass Particles

20-12-2017

Administration of a glass particulate may result in local irritation or swelling in response to the foreign material. More serious potential outcomes...

Food & drugs

Springfield Smoked Fish Expands their Recall of Smoked Salmon Because of Possible Health Risk

20-12-2017

Springfield Smoked Fish of Springfield, MA is expanding their voluntary recall of smoked fish products because they have the potential to be...

Food & drugs

Gel Spice Company, Inc. Issues Allergy Alert On Undeclared Soy And Wheat In Beef Flavored Bouillon Cube Products.

19-12-2017

Gel Spice Company, Inc. is voluntarily recalling certain Spice Time and Spice Supreme Beef Flavored Bouillon Cube products (identified below) because...

Food & drugs

Defibrillation Electrodes for Lifepak AEDs by Physio-Control: Class I Recall - Incorrect Placement Instructions for Infants Dep

19-12-2017

Incorrect placement of electrodes on an infant may result in failure to deliver an effective shock. A delay in therapy could result in serious injury...

Food & drugs

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Pantoprazole Sodium for Injection 40 Mg Per Vial, Due to Presence o

19-12-2017

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Pantoprazole Sodium for Injection 40 mg per vial, to the hospital...

Food & drugs

Jack Brown Produce, Inc. Recalls Gala, Fuji, Honeycrisp and Golden Delicious Apples Due to Possible Health Risk

19-12-2017

Jack Brown Produce, Inc. of Sparta, MI is recalling Gala, Fuji, Honeycrisp and Golden Delicious apples processed and shipped by one of its suppliers,...