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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

HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

22-05-2018

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up...

Product safety

Porsche Recalls Toy Cars Due to Choking Hazard

22-05-2018

The wheels and axles can detach from the wooden toy car, posing a choking hazard to young children.

Food & drugs

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor

21-05-2018

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they...

Food & drugs

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

21-05-2018

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared...

Food & drugs

Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk

21-05-2018

Ziyad Brothers Importing is voluntarily recalling certain lot codes of Ziyad Brand Tahini because it has the potential to be contaminated with...

Food & drugs

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spr

21-05-2018

Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity

Food & drugs

Century Snacks LLC Issues Allergy Alert On Undeclared Milk, Soy, Wheat and Cashews in Snak Club Family Size Tropical Trail Mix

19-05-2018

Century Snacks of Commerce, CA, is recalling certain 16 OZ. bags of Tropical Trail Mix because they may contain milk, soy, wheat and cashew allergens...

Food & drugs

Hickory Harvest Recalls Certain Island Fruit Mix and Organic Nut Mix Products Because of Possible Health Risk

19-05-2018

Hickory Harvest Foods of Akron, Ohio is voluntarily recalling specific lots due to the potential exposure to Listeria monocytogenes. Listeria...

Food & drugs

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops,

18-05-2018

MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm,...

Food & drugs

Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects

18-05-2018

Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or...

Food & drugs

MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate Du

18-05-2018

There is a risk of the delivery wire breaking or separating during use. The clot retriever could be left inside the patient's bloodstream, and this...

Food & drugs

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

18-05-2018

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may...