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# Medical Device Recall Improvement Act Reintroduced
- URL: https://www.fdaweb.com/medical-device-recall-improvement-act-reintroduced/
- Published: 2025-12-11T12:00:00.000Z
- Updated: 2026-09-14T15:28:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160372

Rep. **Jan Schakowsky** (D-IL) and Sen. **Dick Durbin** (D-IL) have reintroduced legislation they say will improve the medical device recall process to protect patients. In a [statement](The%20Medical%20Device%20Recall%20Improvement%20Act%20would%20bolster%20communication%20between%20medical%20device%20manufacturers,%20hospitals%20and%20health%20care%20professionals,%20and%20patients), Schakowsky says the Medical Device Recall Improvement Act would:

- require FDA to establish an electronic format for medical device recall notifications;
- require medical device manufacturers to use the electronic format to contact the agency, hospitals, and healthcare providers; and
- require medical device manufacturers to include information in recall notifications about the risks of the recalled device, and instruct hospitals and healthcare providers to distribute that information to patients.

Medical device manufacturers currently communicate recall information to FDA and healthcare professionals through letters and emails, Schakowsky says. “This extends the amount of time it takes FDA to review recall information, determine a recall classification, and communicate the recall to the public,” she says. “It also extends the amount of time it takes hospital coordinators to track and pull recalled devices from inventories. As a result, patients are often the last informed about a recall, if ever.”