Third quarter data shows 35.8% increase in medical product related recalls, amplifying supply chain pressures as regulations tighten

Dec. 3, 2021

Sedgwick, a provider of technology-enabled risk, benefits and integrated business solutions, published its latest U.S. product recall index report. According to the report findings, the combination of operational challenges and increasingly aggressive safety regulators is leading to increased recalls and enforcement actions across industries.

The report reveals the latest recall data, trends, risks and predictions businesses need to know navigate regulators in the U.S. government and an increasingly collaborative regulatory environment abroad.

This research and analysis was designed and delivered by Sedgwick’s experts in best practice product recall and remediation solutions. Sedgwick works in partnership with clients across all industries to manage the risks and minimize the impacts of in-market business and product crises.

Third quarter recall data for healthcare:

  • After falling for four straight quarters, medical device recalls jumped from 173 events to 235 events quarter-over-quarter, representing a 35.8% increase.
  • Pharmaceutical recalls jumped 45.8% in the third quarter after a three-quarter slide. These 86 recalls impacted 38.1 million units, representing a 65.8% decrease quarter-over-quarter.

Recalls are a hot topic for the medical device industry as the FDA places a renewed emphasis on effective recall management. Manufacturers would be wise to closely monitor the recommendations that come from recent and future meetings, while also finding ways to enhance their own internal processes, thereby limiting regulatory scrutiny, enforcement actions, legal liability and reputational damage.

Pharmaceutical companies should be ready to respond to questions about what the company is doing to ensure the safety of its products. At the same time, action should be taken to mitigate the reputational and litigation risks that will arise if and when a company recalls a product months after an inspection that identified violations of any type.

Sedgwick press release