Report Finds Drug and Medical Device Recalls Skyrocketed in First Quarter of 2022

Both drug and medical device recalls hit record highs in the early months of this year, posing serious health and safety risks for Americans

Recalls involving medical devices and drugs reached new records during the first quarter of 2022, according to a recently released report, which details the vast number of products removed from the market or linked to a serious injury risks over the past few months.

Sedgwick’s Brand Protection’s report, Recall Index First Edition 2022, includes data on all recalls issued in the US during the first quarter of 2022, including pharmaceutical products, medical devices, automotive, consumer products, and food and drink.

According to the report, more than 900 million items across the spectrum of consumer goods have been recalled in the first three months of 2022, nearly surpassing the total units recalled for all of 2021. The units recalled in the first quarter of 2022 was the highest of any quarter in the past 10 years, largely owing to supply and product issues stemming from the pandemic.

Sedgwick’s report is the only report that tracks recall data to help industry professionals understand the impact of recalls, the regulatory environment and other market challenges.

The number of medical devices recalled skyrocketed in the first quarter of 2022, according to the report. Recalls increased by 2,625%. The average recall size exceeded 1.5 million units and the total units recalled surpassed 435 million in the first quarter, reaching a 15-year high.

More than 314 million devices were recalled in the first quarter by companies, up by 11.6 million compared to the final three months of 2021. The increase was largely driven by the Class 3 recall of Becton Dickinson connectors for catheter ports, which included 288 million units.

Other recalls driving the increase included COVID-19 tests triggered by safety concerns of unauthorized diagnostics. A recall of Baxter Sigma Spectrum infusion pumps involved more than a quarter million units.

A large number of pharmaceutical drugs were also recalled in the first quarter of 2022, and have already surpassed the recalled in a full year for the past six years, reaching a 15 year high and exceeding 4.6 million units per recall event.

There were 710 recalls issued by the Food and Drug Administration (FDA) in the first quarter of 2022 for food. The FDA recalled more food in the first three months of 2022 than the four years prior combined.

Additionally, the number of consumer product recalls increased by 161% and automotive recalls increased by 114%.

Labeling issues was the most common reason for recalls. In prior quarters, software issues typically lead to the most recalls.

“While most business operations have adapted to the challenges associated with the ongoing pandemic, new challenges continue to emerge that put businesses at risk,” said Chris Harvey, senior vice president at Sedgwick. “Businesses may also find themselves overwhelmed with the threats to their reputation and their financial success with increased regulatory activity from agencies and lawmakers. Companies should take every opportunity to evaluate and bolster their recall management, crisis and communications plans to ensure they are prepared for the next product crisis.”