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Food & drugs

Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error

12-11-2020

The Cook Fixed Core Wire Guide is a curved wire guide made of stainless steel with non-reactive coating and helps insert medical devices into the body.

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Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

09-11-2020

Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced...

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2020 Medical Device Recalls

09-11-2020

List of Medical Device recalls in 2020.

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Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

09-11-2020

Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced...

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Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use

09-11-2020

Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use

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Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination

06-11-2020

Out of an abundance of caution, Tanimura & Antle Inc. is voluntarily recalling its packaged single head romaine lettuce under the Tanimura & Antle brand, labeled with a packed on date of 10/15/2020 or 10/16/2020, due to possible contamination with...

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2020 Medical Device Recalls

03-11-2020

List of Medical Device recalls in 2020.

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Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-N

03-11-2020

Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine...

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Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues

03-11-2020

Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues

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Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff

03-11-2020

Laboratories should expect some false positive results when screening large populations with a low prevalence of COVID-19 infection.

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Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-N

02-11-2020

Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain...

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Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-N

02-11-2020

Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain...

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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...

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