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Category Archives: Recalls

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2014 – FDA Recalls DePuy Craniomaxillofacial Distraction System, Cites Fatal Risk

Posted in Devices, FDA Regulation, Recalls

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled.  This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic… Continue Reading

FDA Recall Safety Alert: Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels

Posted in Recalls

On August 21st, the US Food and Drug Administration issued a Class-1 recall for Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels, affecting “78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.” (FDA) These panels come as part of kits used by medical professionals to test a patient’s saliva or tissue for… Continue Reading

2013 – “California Firm Recalls Bolognese Sauce Products Due To Undeclared Allergen And Misbranding”

Posted in Public Health, Recalls

An article titled “California Firm Recalls Bolognese Sauce Products Due To Undeclared Allergen And Misbranding”, written by the United States Department of Agriculture’s Food Safety and Inspection Service, reports that the agency has forced the recall of 5,616 pounds of Armanino brand Bolognese sauce products.  The company did not properly label all of their products… Continue Reading

WARNING: FDA recall on OxyElite Pro due to connection with “serious adverse health consequences, namely serious liver damage or acute liver failure”

Posted in Public Health, Recalls

On 11-9-2013, the FDA announced a recall of dietary supplement OxyElite Pro (USPlabs LLC, Dallas) “after officials linked it to cases of liver failure and acute hepatitis in 29 people” in Hawaii, CNN reports. Several sources now report that one of two patients who required liver transplants has died.  WebMD writes that other people “are… Continue Reading

FDA Recall Safety Alert: Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels

Posted in Recalls, Safety Alerts

On August 21st, the US Food and Drug Administration issued a Class-1 recall for Siemens MicroScan Synergies plus® and MicroScan® rapID/S plus Negative Panels, affecting “78,020 panels distributed in the US between 07/11/2011 and 08/02/2013.” (FDA) These panels come as part of kits used by medical professionals to test a patient’s saliva or tissue for… Continue Reading

Olympia Pharmacy (FL) recalls “all sterile drug products”

Posted in Recalls

Citing concerns about sterility, Lowlite Investments (d/b/a Olympia Pharmacy) in Orlando, FL has recently recalled “all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product,” according to a recent FDA report. With respect to the present concern over the safety of products sold as sterile by… Continue Reading

Nationwide FDA Recall: ‘All sterile products’ from Specialty Compounding

Posted in Recalls

On August 11th of this year, the United States Food and Drug Administration issued a “nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX.  There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.”[1] So far, “The FDA has… Continue Reading

SynchroMed Infusion Pumps Recalled by FDA

Posted in Devices, Recalls, SynchroMed Infusion Pumps

In a current announcement recorded in the Star Tribune, Medtronic, Inc. reported that 14 total patient deaths have occurred in connection to their SynchroMed infusion pumps.  The deaths have been reported as occurring between spring of 1996 and spring of 2013.  The article reports that just one day prior to the public announcement from Medtronic, the… Continue Reading

Premium Edge Cat Food Recalled

Posted in Recalls, Safety Alerts

If you have a furry little friend who eats Premium Edge cat food, you’ll want to read this: On September 23, Diamond Pet Foods issued a voluntary recall for Premium Edge Finicky Adult Cat and Premium Edge Hairball cat because they have the potential to produce Thiamine Deficiency. Today’s announcement provides additional information from the… Continue Reading

Complete List of Recalled Children’s Tylenol

Posted in Recalls

You’ve probably heard that Children’s Tylenol was recalled earlier this month.  Fresh from the FDA, here’s the complete list of all products that were recalled.  If you have any of them, DON’T USE THEM. 1) Children's Tylenol Plus, Multi-Symptom Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg,… Continue Reading

More Fentanyl patches recalled – not Duragesic this time

Posted in Duragesic / Fentanyl, Recalls

Watson Pharmaceuticals has announced a recall of all 75mcg Fentanyl patches from lot number 92461850.  These patches are being recalled for the same reason many of Johnson & Johnson’s Duragesic patches were recalled: Manufacturing defects that could lead to leakage.  Here’s an excerpt from Watson’s press release: CORONA, CA – August 8, 2008 – Watson… Continue Reading