13 recent drug, device recalls

Here are 13 drug and medical device recalls the FDA reported in August: 

1. North American Diagnostics recalled more than 120,000 COVID-19 tests in a class 1 recall, the most serious type, because the company did not send data to the FDA on the efficacy of the tests. No deaths or injuries have been reported. 

2. Distributor RFR recalled one lot of its male sexual enhancement drug, Sangter, because of a contamination of a material found in erectile dysfunction treatments. The product "may cause a significant drop in blood pressure that may be life threatening," according to the FDA. There have been no injuries or deaths reported. 

3.  Loud Muscle Science recalled seven lots in the U.S. of its male sexual enhancement treatment, Launch Sequence, because of a contamination of an ingredient used in erectile dysfunction drugs. No deaths or injuries have been reported. 

4. Vi-Jon expanded its recall for the second time to include all flavors of its constipation treatment, which was sold at CVS, because of a microbial contamination that could have "serious, life threatening" results for some people. Three adverse reactions have been reported. 

5. Plastikon Healthcare expanded its recall of its constipation drug, which was recalled at the retail level in June and is now recalled at the consumer level, because of a microbial contamination. There have been no adverse reactions reported. 

6. Haimen Shengbang Laboratory Equipment recalled more than 4 million transport media containers, which include a swab and a tube containing viral sampling liquid, because the product is not approved by the FDA. The lack of FDA approval could result in a false negative or false positive, which could "cause serious adverse health consequences or death." No complaints or injuries have been reported. 

7. Becton Dickinson recalled 34,355 needle sets and more than 2,200 drills because of separation and deployment issues. There have been 37 complaints but no injuries or deaths reported. 

8. Medtronic recalled more than 87,000 defibrillators in a class 1 recall after 27 complaints have reported the device delivering an electric shock at a too-low voltage, which could be deadly. No serious injuries or deaths have been reported. 

9. Hospira expanded its July recall to include a second lot of Propofol Injectable Emulsion because of a visible particulate. Hospira, a Pfizer company, has not reported any adverse reactions from either recall. 

10. Medtronic recalled more than 23,000 HeartWare Ventricular Assist Device batteries in a class 1 recall because of an electrical issue that could cause them to fail. There have been 1,159 complaints, six injuries and one death related to this recall, according to the FDA. 

11. Intera Oncology recalled 440 infusion pumps after physicians reported flow rates faster than expected. There have been three complaints, no injuries and no deaths reported. 

12. Hamilton Medical recalled nearly 500 ventilators in a class 1 recall because of a hardware issue in which liquid enters between the indicator board and the ventilator's main board, causing the patient to breathe ambient room air. There have been 128 complaints, no injuries and no deaths reported. 

13. Philips Respironics recalled 386 ventilators because of a plastic defect. No serious injuries or deaths have been reported.

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