Be 'recall ready': FDA asks companies to take potentially harmful products off the market faster

Though the FDA has the authority to call for a recall of any medical device or other regulated product that it deems a potential risk to public health, the agency is asking for assistance from manufacturers to get affected products off the market as quickly as possible.

This month, the FDA finalized guidance outlining how makers of regulated products can become “recall ready” to minimize buyers’ and users’ exposure to any potential health risks.

The guidance urges companies to prepare for recalls by installing a series of internal policies and procedures, and, once a recall is necessary, to move quickly in carrying out those procedures.

“Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe,” said Judith McMeekin, Pharm. D., the FDA’s associate commissioner of regulatory affairs.

“It is critical that all companies in the supply chain are 'recall ready' to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain,” McMeekin said in an agency statement. “We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”

To start, according to the regulator, companies should set up product coding systems and keep thorough distribution logs so that they can more easily and accurately single out specific lots of potentially harmful products.

From there, as they begin to alert buyers and patients about an identified safety risk, product makers are encouraged to use electronic communication methods to send out those alerts—once again, to ensure the public becomes aware of the risk as quickly as possible.

In a final attempt at speeding up the recall process, the FDA also asked companies to initiate voluntary recalls as soon as they learn of a potential issue with their products, rather than waiting for the results of an investigation into the issue. They should also immediately notify all suppliers, distributors and other partners along the supply chain to keep as many affected products as possible out of the public’s hands.

The new guidance comes as the FDA reported a sharp drop in the number of product recalls for its fiscal year 2021, which ended September 30.

According to the agency’s recall data dashboard, 5,310 products were recalled in 2021. That’s not only well below 2020’s tally of 7,252 recalls but also represents the lowest number of annual recalls since the 3,208 it reported in fiscal year 2012, the first year with publicly available recall data.