Recalls

The FDA issued several medical device recalls in July 2024, impacting companies like Inspire Medical Systems, Philips North America, Hamilton Medical, Baxter International, Bausch + Lomb/Synergetics, and Abbott Laboratories. The recalls address issues ranging from manufacturing defects and software malfunctions to potential non-sterility and inaccurate readings. These recalls highlight the critical importance of post-market surveillance to ensure patient safety.

Smiths Medical issued a correction letter regarding two potential issues with the CADD Infusion System Infusion Sets: lack of delivery or under delivery of medication, and false "no disposable attached" alarms.

According to the U.S. product recall index released by Sedgwick’s brand protection division, Q3 2022 U.S. recall data show that the number of products recalled this year has officially reached a 20-year high

Insulet Recalls Omnipod DASH for Battery Swelling, Leakage, or Extreme Overheating

Google recalls the Fitbit Ionic for causing burn injuries

A recent report by Sedgwick found that manufacturing defects are now the leading cause of medical device recalls in the U.S. This marks the first time in 12 years that quality issues, not malfunctions or sterility problems, are to blame

With Philips agreeing to pay out hundreds of millions in its initial settlement over its recalled respiratory devices, the company's ventilator crisis exemplifies the severe consequences device makers can face if product quality issues are not addressed proactively. The settlement provides critical but costly lessons for manufacturers seeking to avoid similar recall pitfalls going forward.