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2020 Medical Device Recalls

12-05-2020

List of Medical Device recalls in 2020.

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Applied Medical Recalls Python Embolectomy, BARD Embolectomy, and OTW Latis Cleaning Catheters Due to Risk of Separation During

12-05-2020

The identified catheters are latex balloon catheters used for temporary blockage, closing of a blood vessel, or infusion of fluids. These catheters are at risk of tip detachment which could lead to pieces of the catheter breaking off. This could...

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UNFI Voluntarily Recalls Wild Harvest® Organic Basil Due to Possible Health Risk

11-05-2020

United Natural Foods, Inc. (UNFI) is initiating a voluntary recall of a limited quantity of Wild Harvest® Organic Basil distributed out of UNFI’s Hopkins, MN distribution center to select retailers in Minnesota between 4/18/2020-5/8/2020....

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MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypert

11-05-2020

MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found...

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ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter

08-05-2020

ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware...

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ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter

08-05-2020

ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware...

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Zilk’s Plus Resources Issues Allergy Alert on Undeclared Milk, Soy, and Wheat in Select 12 Oz Bottled Sauces

08-05-2020

Zilk’s Plus Resources, LLC of Austin, TX announces a voluntary recall for select 12 oz bottles of Pluckers World Famous Wing Sauces because they may contain undeclared allergens.

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Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Prov

07-05-2020

The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH.

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Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers

07-05-2020

3M Comply Hydrogen Peroxide Chemical Indicator 1248 and Aesculap MD334 Process Indicator Card use different colors to indicate a sterilized device.

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Becca Cosmetics voluntarily recalls Light Shifter Brightening Concealer

07-05-2020

Out of abundance of caution, and in line with its commitment to consumer satisfaction and safety, Becca Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common...

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MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypert

06-05-2020

MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found...

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The Essential Baking Company Issues Allergen Alert on Undeclared Egg in 84 Loaves of 32 Oz. Sliced Columbia Bread

05-05-2020

The Essential Baking Company of Seattle, Washington is recalling 84 loaves of 32 oz. Sliced Columbia Bread, expiration date May 6.20, due to undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or...

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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...

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