Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Over the course of 2020, several large-scale recalls of medical devices, supplies and drugs have taken place.
Eight of the largest recalls this year:
Editor's note: This is not a comprehensive list. Recalls are listed in chronological order.
- Cardinal Health issued a voluntary recall Jan. 22 of 9.1 million surgical gowns after finding potential quality issues, including that they were made in an open environment where gowns were exposed to air particulate and other contaminants. Johnson City, Tenn.-based Ballad Health announced it had suspended about 200 elective surgeries after receiving a warning from Cardinal that some of its gowns may not be sterile.
- Cardinal Health recalled Jan. 31 2.5 million of its Presource Procedure Packs that contain the surgical gowns that were recalled. Cardinal's CEO later said the gown recalls cost the company $96 million.
- Medtronic recalled 322,005 of its MiniMed 600 series insulin pumps Feb. 12 after discovering a problem that can cause the user to be given the wrong dose of insulin. The company received 26,421 complaints and reports of 2,175 injuries and one death related to the pumps.
- Devicemakers Abbott, ResMed and Teleflex all announced high-risk medical device recalls on Feb. 20. Abbott recalled 13,891 of its coronary dilation catheters, used to open clogged blood vessels, often in heart attack patients. Teleflex recalled its Comfort Flo humidification system used to provide breathing gases to patients. ResMed recalled its Stellar ventilators used to provide breathing support to patients. All three were classified as Class I recalls.
- Becton Dickinson recalled 774,000 of its Alaris System Pump Modules March 6 after several system and software errors caused 55 injuries and one death.
- The FDA asked all drugmakers April 2 to pull ranitidine products from the shelves after finding "unacceptable levels" of a possible carcinogen can develop in the products over time.
- The FDA asked five drugmakers June 2 to voluntarily recall their metformin products after it found unacceptable levels of a carcinogen in the drug. The agency said May 28 that after months of testing, it found unacceptable levels of N-nitrosodimethylamine, or NDMA, a cancer-causing chemical when ingested at high levels, in extended-release versions of metformin. Since then, dozens of drugmakers have recalled their metformin products.
- The FDA warned June 23 that nine types of hand sanitizer may contain methanol, a toxic substance when absorbed through the skin or ingested. The agency later published a list of 55 hand sanitizers that may contain methanol and said it was aware of people who have died from methanol poisoning after using the hand sanitizers. In late July, the FDA put certain brands of hand sanitizers on import alert to prevent more people from being exposed to methanol poisoning. At least 15 hospitalizations have been linked to methanol poisoning associated with the contaminated hand sanitizers.