Mass Recalls from FDA including Class 1 (most serious, lethal or severe injury may result from use of product). Please bookmark the FDA website and check back regular for recalls, contamination of products with deadly fungal and bacteria is occurring on a wide scale in multiple products. Additionally, large scale food recalls have also been occurring with alarming frequency. This site also adds a partial list of serious recalls to this post week, so bookmark and check back for updates on the most serious recall issues.
FDA recall page:
Archived Covid Test Recall Page - FDA has basically hidden this page on their updated website, original screen capture included at bottom of page. They are NOT adding new recalls to this list, it was last updated in July. (bookmark this page, new recalls will be added under update section)
Bacterial & fungal contamination of Covid-19 testing kits and devices, and large scale recalls of contaminated medical devices has been an on-going and serious issue through the Covid-19 attributed pandemic. The FDA has recalled tens of millions of testing kits and medical devices with recalls due to mold and bacterial contamination occurring around the globe. Several large scale FDA Class 1 recalls of medical devices have occurred in 2021 due to mold and bacterial contamination. Pfizer is (again) in the spotlight as ALL lots of Chantix have been pulled from the market nationwide due to cancer risk.
*Recommended companion reading:
Tens of millions of Covid-19 testing kits, devices, and nasal swabs have been removed from the US & global market due to contamination issues since the beginning of the testing program in March, 2020. 264 different Covid-19 testing kits and devices have been recalled by the FDA.
-Covid-19 testing swabs, along with contaminated oxygen, are now implicated in very rare and highly lethal black fungal outbreaks in India. India is also experiencing outbreaks of Aspergillious and other fungal infections throughout the country
-Recalls of faulty Emergency Use Only Covid-19 testing kits have become status quo with a new recall issued on May 28, 2021 for eight million Lepu technology Antigen & Leaccurate Antibody Test Kits
- a mass Class 1 FDA recall of medical device kits from Medical Action Industries for 306 different medical kits was issued on April 9, 2021 for kits distributed between December 12, 2019 and April 9, 2021 due to Aspergillious Pennicillioides. Aspergillious has been a noted secondary occurring infection in individuals with serious Covid-19 attributed infections, These are not Covid-19 test kits, however, individuals in hospital settings receiving treatments with the contaminated medical devices including syringes and swabs as well as health care professionals implementing care may be effected according to the recall notice. Level one recalls are the most serious category of FDA recall with the potential use of products leading to severe injury and death. Kits have been in distribution since the beginning of the Covid-19 attributed pandemic.
-mass contamination and recalls of faulty testing are documented by public health organization websites & reports in mainstream news sources, contamination issues were wide-spread across the globe
-A NCBI Study found the highly rare mucormycosis infection (black fungal infection which is now a pandemic in India) to be associated with Covid-19
-750,000 Randox Covid-19 Tests were removed from the market in the UK due to 'safety issues' with nasal swabs
-Mass contamination has been a ongoing issue with the first CDC Covid-19 testing kits released to the public found to be contaminated upon investigation
-No US investigation into the health effects of use of contaminated swabs on citizens or inquiry into tens of millions of dollars spent on wasted tests have been implemented
Scroll down past updates to read original story;
Update November 12:
FDA recalls 2 million tests for potential false positives
October 29 Update:
Ethylene Oxide Contaminated Covid-19 Rapid Testing
Another produce recall for Listeria Monocytogenes for potentially fatal infections & still birth:
October 26 Update:
900,000 tests used in German schools found contaminated with bacteria, took authorities WEEKS to respond (click here for article in German, will translate in Google to English from Nordkurier, MSM German news source HERE)
October 19: Mass Blood Pressure Drug Recall - Cancer Risk:
October 15 Update:
October 6 UPDATE:
FDA recalls another rapid antigen test kit for false positives (antigen tests produce up to 100% false positives in low incidence populations per FDA statement on November 3, 2021, all antigen tests need to cease)
FDA adds more hand sanitizers to recall list. Hand Sanitizers recalled for risk of cancer. Over 255 hand sanitizers have been recalled due to contamination or cancer risk.
Mass Benzene recalls continue. Benzene is a carcinogen and over 50 products from sunscreens to cosmetics have been added to the FDA recall list so far this year.
FDA recalls of half million insulin pumps due to potential for remote hacking to stop insulin delivery or change administration dose. Recall also extends to component problems with pumps:
"By the time of the original August 2018 recall, though, Medtronic had identified a cybersecurity risk present in remote controllers distributed between August 1999 and July 2018. With specialized equipment, an unauthorized person could potentially hack into the connection between the controller and the pump and cause the pump to either deliver too much insulin or completely stop insulin delivery".
SERIOUS listeria monocytogenes bacteria contamination recall by FDA which can result in stillbirth in pregnant women.
Disturbingly, a search for more information on this bacteria found this research article detailing the use of this lethal bacteria as a main ingredient for a vaccine against Francisella tularensis. Both are potentially lethal bacteria infections:
September 24 Update:
Ultrasound gel recall due to Burkholderia cepacia contamination (level 1 recall -may cause serious illness or death). This follows multi-state outbreak of infections in early August:
This bacteria has been studied as a potential bioweapon
SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination (may cause life threatening septic infection - the recall does not list specific microbial contaminant)
FDA level 1 recall MedTech
Cordis issues Class I FDA recall of angiographic catheters that could leave metal pieces in arteries
ALL Pfizer Chantix tabs on market recalled (smoking cessation drug) for high levels of nitrosamine, N-nitroso-varenicline above FDA limitis (carcinogen
September 13 Update:
Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination Potential Life Threatening infections (no listing of specific contaminants included in recall list)
FDA recall list may be viewed HERE.
Original Story HERE:.............
The Covid-19 testing program has been seriously compromised through use of tests non-specific to Covid-19, erroneous testing protocol recommendations and contamination issues. Emergency Use Only approved RT PCRT tests were found by credible peer review by twenty two international experts to be 'useless' for detection of Sars CoV-2 ( the virus attributed to cause Covid-19 infections). PCR testing is the central test utilized by the US and around the globe for diagnosis of Covid-19 infection. Additionally, it was exposed last summer through interviews with Dr Anthony Fauci and medical research studies highlighted in the New York Times that the majority of positive test results were actually false positives due to a simple testing recommendation error. Review of Emergency Test Use guidelines by the CDC and FDA also reveal testing was developed without Sars CoV-2 isolates. Numerous updates and recalls by the FDA for Covid-19 testing devices and swabs have been issued with the FDA warning last November 3 that Antigen tests implemented in low incident rate populations for Covid-19 would produce up to 100% false positive tests. 264 test recalls have been issued for Covid-19 testing kits and devices since last Spring. Additionally, there is extensive evidence that the CDC, FDA, and WHO have been implementing testing directives in ways that will raise or lower case numbers for policy aims. For a full discussion of this issue, see HERE.
And, while the problems with RT PCR testing reliability have been extensively covered by independent media, and even some mainstream news outlets, the issue of extensive contamination of Covid-19 testing kits & swabs has not garnered the same level of attention.
Mass release of contaminated test kits, swabs, and devices have been occurring since the inception of the testing program in March 2020. The CDC has admitted that it knowingly released compromised and contaminated testing, and the early release of severely flawed testing has been acknowledged to have compromised the accuracy of Covid-infection numbers by major media outlets due to false positive results:
"WASHINGTON (SBG) - An internal investigation at the Department of Health and Human Services into why the Centers for Disease Control and Prevention (CDC) shipped defective coronavirus test kits to public health laboratories in February – a failing some experts have cited as a hindrance to America’s critical early efforts to combat the outbreak – has concluded, according to a final report obtained by Sinclair, that CDC scientists likely used a component in the kits that was “contaminated.”
The Post has previously reported that the test kits have produced false-positive results caused by the CDC’s contamination. An examination by the Food and Drug Administration (FDA) concluded that the tests failed because of substandard manufacturing practices and that the CDC violated its own laboratory protocol in making the kits".
Numerous recalls due to contamination have occurred throughout the pandemic including:
The University of Washington stopped using 12,000 Made in China tests after contamination with Stenotrophomonas maltophilia was discovered:
"The University of Washington has stopped using them. The liquid in many vials changed colour or became cloudy. The Shanghai manufacturer will refund US$ 125,000. Defective and inaccurate testing kits were also sold in Spain, Czechia, the Philippines, and Malaysia. Defective masks sold to the Netherlands.
The same bacteria was found in Covid-19 testing kits in a DHEC lab in South Carolina rendering the tests unusable with the news report stating the lab was aware of the same contamination issues being experienced by other labs throughout the U.S:
"They are getting supplies from the federal government, and periodically, they receive supplies they cannot use - “for example, transport media,” Duwve said.
Transport media is a solution that is used to preserve bacteria, such as that found with a COVID-19 test, during transport and helps to maintain the specimen in its original state. Duwve said thousands of tubes were unusable because they had been contaminated or they reacted poorly to bleach.
The State Emergency Response Team told WMBF News that they received about 25,000 vials of the liquid that was sealed in plastic bags. Lab analysts noticed the liquid was discolored.
They had also been aware that other public health labs around the country received some similar contaminated solution. Lab analysts for DHEC plated samples of the media and found that it had a heavy growth of the organism Stenotrophomonas maltophilia, which had been recovered by other public health labs as well. Right now it’s not clear what caused the contamination but officials believe it was some kind of production issue".
Stenotrophomonas Maltophilia is a common attributed infection in individuals with severe Covid-19 attributed infections according to a research study published on Pub Med:
"Most common pathogens detected were Stenotrophomonas maltophilia (28.0%) and Pseudomonas aeruginosa (28.0%) in the severe group and S. maltophilia (45.5%) in the critical group. P. aeruginosa was detected more during the early stage after ICU admission.
The Toronto Star reported in April 2021 that 100,000 swabs from China were contaminated with mold:
"The shipment of much-needed swabs, a critical component of the testing, was the first instalment of a big order procured by the federal government, with hundreds of thousands of more from the contaminated batch on the way. The contamination is believed to be mold".
Right now in India, there is a mass outbreak of a highly rare fungal infection, mucormycosis, with cases usually numbering only in the single digits with only highly localized clusters. Thousands of the highly lethal black fungal infection have been diagnosed throughout multiple municipalities in India resulting in the India government declaring the infection an epidemic.
Indian officials now believe Covid-19 test swabs and oxygen containers are the originating source for the contamination. India has reported a major oxygen crisis although the Prime Minister has stated that the country has more supply of oxygen on hand than at any other time since the crisis began.
"PM also took stock of the situation on oxygen availability and supply in the country. It was discussed that the supply of oxygen is now more than 3 times the supply during the peak of first wave. PM was briefed about the operations of oxygen rail and sorties by IAF planes. PM was also informed about the status of procurement of Oxygen concentrators, oxygen cylinders as well as the status of PSA plants being installed across the country"
Experts working on tracing the origin of mucormycosis state the testing swabs may be source of the infection:
"Experts working in Covid wards in top government hospitals specialising in infectious diseases have made some startling revelations to Outlook -- the reason for the spread of Mucormycosis or black fungus among many Covid-19 recovered patients could be contaminated nasal swab used during testing:
And, while public health officials have been citing use of steroids for a possible reason in increase in infections (do to decreased immune function from the drug) and oxygen for the source of contamination, experts say majority with infection had neither of these contributing factors:
After observing several such patients, they are of the view that the insertion of a swab (a cotton ball) in the nose during the RT-PCR test could be one of the main reasons for the outbreak of this fungal disease.
They say that on questioning, these patients said that they underwent RT-PCR tests multiple times to find out if they are Covid positive or not. This has made the doctors believe that it could be due to swabs".
"Last year, during the first wave, a global study titled “The emergence of Covid-19 associated Mucormycosis: Analysis of cases from 18 countries” was done on 80 patients, 42 of them were from India. One of the noted microbiologists, Arunaloke Chakarabatri, MD, Professor, Department of Microbiology, Postgraduate Institute of Medical Education and Research, Chandigarh was part of this study team. The study had established that 41 out of 42 patients from India had a fungal infection in the sinuses, nasal passage, oral cavity, and brain. Only one patient had it in the lungs. Such infections were not found so widely among patients in developed countries".
Experts have attempted to blame 'dirty' oxygen containers and ventilators for fostering the development of murcormycosis, however some experts point out that none of these conditions are new and does not explain for the outbreak of a highly rare fungal disease:
“Hospitals were dirty even before April. We need epidemiological studies to assess why these cases are rising now,” said SP Kalantri, senior doctor and researcher at the Mahatma Gandhi Institute of Medical Sciences in Maharashtra.
"Dr Sampath Chandra said during his presentation that the probable reasons for the surge in black fungus could be due to contamination either due to low-quality cylinders or low-quality piping system at the ICU level in hospitals or contamination at the industry level, from where the oxygen is being supplied"
India's mucormycosis outbreak began in December when experts began attributing the infection to Covid-19 patients after an outbreak in New Dehli & Amhedabad. Immune compromised status, however, only explains why an individual may be more at risk for development of mucormycosis infection, it does not explain the sudden and wide spread presence of the rare mold multiple regions or identify originating source. Nasal swab contamination would answer why individuals with positive PCR tests for Covid-19 were developing the condition, although the outbreak has not been limited to individuals with Covid-19 attributed infections.
For a full discussion on the fungal infection outbreak in India, please see HERE.
The UK also identified mass contamination of Covid-19 testing kits. 3/4 of a million Randox Covid-19 tests were recalled due to safety concerns:
The packs have been sent out by healthcare giant Randox to care homes and individuals throughout the pandemic.
But on Saturday morning the UK’s Medicines and Healthcare Products Regulatory Agency asked the company to recall up to 750,000 of the kits after safety issues emerged.
Exactly what those issues are has not been revealed but it is understood the Department for Health and Social Care has asked for the sterility of some swabs to be independently verified".
The use of Randox as a vendor for production of Covid-19 testing kits was controversial due to the company's history of scandal with Randox employees found to be manipulating drug test results to ensure convictions in court cases:
"More than 10,000 criminal cases may have been affected by alleged manipulation at a forensics lab that analysed evidence of drug driving, violent crime, sexual offences and unexplained deaths, it has been revealed.
Around 50 cases that were due to go to trial have been dropped over the scandal at a Randox Testing Services laboratory in Manchester, the National Police Chiefs’ Council (NPCC) said. Two road deaths have been referred to the Court of Appeal.
They are just a fraction of the alleged cases across 42 police force areas in England and Wales that could be affected by the alleged data manipulation, which dates back to 2013. The cases could result in court hearings being adjourned or thrown out because of the need for retesting".
Contamination issues date back to last Spring. European countries issued a mass recall of early Chinese tests after they were deemed faulty and unreliable:
Despite extensive documentation of mass contamination and production of tens of millions of Covid-19 testing kits, devices, and swabs by the FDA & 256 recalls of these tests, no investigation has been implemented to study possible health effects on the use of compromised test equipment to public.
The United States has spent billions of dollars on faulty and unreliable testing for Covid-19 testing which has been documented to be unsuitable for detection of Sars CoV2 (virus attributed to Covid-19). New allocations of billions of dollars continue to be reserved for this testing, often from the same vendors which produced millions of recalled tests.
Health care professionals have organized to stop all unnecessary and harmful Covid-19 testing directives. For full petition, please go HERE:
FDA list of 264 recalled Covid-19 testing kits and devices, compromising tens of millions of tests:
A
https://www.aljazeera.com/news/2021/5/24/what-is-black-fungus-that-is-hitting-indias-covid-19-patients