Medical Device Recalls - Part 1: High Level Overview

A high level overview of 283 Class I recalls of medical devices in the last 3 years.

Medical device recalls classified by the FDA as Class I represent the most serious type. If these issues ware not addressed adequately, there is a high chance that patients and users will experience serious injuries including life threatening conditions and death. That is why it is useful to actively monitor device recalls as part of your post-market surveillance process and take timely action before it is too late.

A recent article¹ presented the following findings based on analysis of 189 Class I recalls from January 1, 2018 to June 30, 2022 for moderate to high risk medical devices:

• Approximately 80% of the 189 Class I recalls were for moderate risk devices (Class II) and 18% for high risk devices (Class III).

• Cardiovascular medical specialty accounted for 34% of recalls, followed by Anesthesiology (21%) and General Hospital (17%). 19% of recalls involved implanted devices.

• Device design was the most frequent cause for recalls (~55%) followed by issues in manufacturing/processing (~25%) and software (11%).

• The median number of device units per recall notice was 4620 with around 6% of recalls involving more than 1 million device units.

• 125 devices (66%) were involved in multiple recalls with a median of 4 recalls issued per recalled device.

• As of September 15, 2022, 50 (~27%) recalls were terminated with a median of 24 months elapsed since they were initiated.

More importantly, the authors presented the following conclusion:

Class I medical device recalls are common and affect millions of device units in use in the US. Completing the required actions for recall termination takes a significant amount of time, posing serious safety concerns to patients for a longer period.

In this article, we extend the analysis of recalls data to class I recalls reported from July 1, 2022 to May 31, 2025. Our intent is to seek deeper insights, not simply replicate the analysis and inferences reported in the above article.

Class I recalls data was extracted from Orca1.ai, a comprehensive analytics platform for life sciences.