The world of medicine is constantly pumping out new products to help cure common ailments and save lives. Unfortunately, despite originally earning approval from the FDA, thousands of medical devices and products are recalled and pulled from the market each year. Here are some of the most surprising recalls to date.
1. Abbott Pacemakers
One of the biggest medical device recalls in recent history involved pacemakers created by the company, Abbott. In 2017, the company decided of its own volition to recall nearly 500,000 of its pacemakers after realizing that they had a cyber-security flaw. The issue was that the pacemakers could be hacked by a third party, who could then remotely control the tempo of the device, causing it to slow down or speed up. Thankfully, no patients with this device were harmed, and the company created an update that required authorization for anyone trying to access the pacemakers, solving the cyber-security issue.
2. Thalidomide
You might be shocked to hear that before 1962, manufacturers were not required to prove the effectiveness of their drugs before selling them to the public. Additionally, they were not required to document and report any side effects that they discovered after introducing them to the market. In 1962, amendments were made to the Federal Food, Drug, and Cosmetic Act. These amendments were sparked by the 1961 recall of the drug Thalidomide. This drug started out being sold as a sedative but ended up being marketed to treat many common cold and flu symptoms and was sold primarily over the counter to pregnant women in the 50s as a drug to help combat morning sickness.
Unfortunately, the drug led to more than 10,000 cases of severe birth defects, which caused it to be recalled in 1961. Despite the shocking fact that this drug was never actually approved for sale in the United States, it was prescribed by doctors to nearly 20,000. While this drug led to a lot of suffering for many families, it helped to spark discussion over the importance of drug toxicology testing in the United States, ultimately preventing harm for many others.
3. Physio-Control Defibrillators
Another shocking recall came in 2017, when the portable defibrillation company, Physio-Control, was forced to recall over 100 copies of their device. This recall came as a result of some medical professionals noticing that the devices were having electrical problems. These problems did not allow the device to provide enough energy to deliver the appropriate shock to revive a patient suffering from cardiac arrest. Most obviously, this issue could lead to the death of a patient, but, if the patient were still successfully revived, it could also cause brain injury or permanent organ damage. Once the issue was realized, the company instructed anyone with the device to conduct daily tests to determine its functionality. If the device failed the test, it was then delivered back to the company to be repaired. While this was not a particularly large recall, it did have severe consequences for those who suffered from it.
4. Tylenol
That’s right. You might not have realized it, but Tylenol was recalled en-masse in 1982. The recall wasn’t due to any harmful side effects associated with the drug, or any impurities in a particular batch, but because the company decided that the bottles that the common drug came in were not secure enough. This decision was sparked by the Chicago Tylenol murders. Within one week in September of 1982, seven people died after taking Tylenol. Investigators discovered that the murderer had tampered with the bottles of the drugs, replacing the medicine inside of the capsules with cyanide. Several copycat murders followed, pushing the FDA to recall the common drug. While the original murderer was never found, the act did lead to new safety precautions in the world of pharmaceuticals, giving us the tamper-proof packaging that all drugs are required to come in today.
5. Diethylstilbestrol
Pregnant women had it rough in the mid-1900s. In addition to the previously mentioned Thalidomide, expecting mothers were also prescribed Diethylstilbestrol by their doctors. This drug was supposed to aid in the production of estrogen during pregnancy, preventing miscarriages and other complications. Even though it was eventually proved ineffective, doctors continued to prescribe it to pregnant women for nearly two decades. In 1971, it was discovered that this useless drug was a carcinogen that caused rare vaginal tumors in girls and women who had been exposed to it in utero. The FDA recalled the drug immediately and the manufacturers were required to pay over a billion dollars to the victims.
We are not doctors and this is in no way intended to be used as medical advice and we cannot be held responsible for your results. As with any product, service or supplement, use at your own risk. Always do your own research before using.
We are not lawyers and this is in no way intended to be used as legal advice . We cannot be held responsible for your results. Always do your own research and seek professional legal help.
Meg is an author at Cinnamon Hollow. She writes on a variety of topics sharing tips and ideas for daily life.