# 119-hr-6594: Medical Device Recall Improvement Act of 2025

119-hr-6594, Medical Device Recall Improvement Act of 2025, is a 119th Congress bill sponsored by Rep. Schakowsky, Janice D. [D-IL-9] (D-IL); status introduced; PRIA reads it as touching household money (as of 2026-04-21).

- Canonical: https://policyrisk.com/legislation/119-hr-6594
- As of: 2026-04-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-6594
- Congress: 119
- Title: Medical Device Recall Improvement Act of 2025
- Status: introduced
- Introduced: 2025-12-10
- Sponsor: Rep. Schakowsky, Janice D. [D-IL-9] (D-IL)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-04-21

## Summary

**Creates a standardized electronic system for medical device recall notifications and patient-facing risk communication.** It would require manufacturers to file recalls on a single electronic form, set short review timelines, fund a public database, and add penalties for failures to notify. - Patients and families: Would get clearer notices for certain high-risk recalls. Notices must include the device risk and steps patients can take, and apply to implanted devices, life-sustaining or life-supporting devices, and devices used significantly in pediatric care when recalled outside health facilities. - Manufacturers and importers: Would have to submit recalls using the new electronic form starting 180 days after the form is established. The Secretary would conduct an initial review within two business days and notify the firm within three business days what will be shared with providers, and new prohibited acts would cover failures to submit or notify. - Device user facilities and health professionals: Would receive initial notifications after the Secretary’s review and further updates as needed. They would not be required to send patient contact information to manufacturers. - Public access: The Secretary would maintain a publicly accessible electronic database populated with recall notification information. *Would authorize about $6.7 million in FY2026, $1.7 million in FY2027, and $1.0 million annually for FY2028–2030 to implement and run the system, increasing federal spending by those amounts.*

## Cosponsors (1)

- Rep. Carson, André [D-IN-7] (D-IN), 2025-12-10T00:00:00.000Z

## Provisions PRIA read

- Patient notices for certain devices: benefit, medium. If enacted, the FDA would require recall plans to include notice to patients treated with certain recalled devices. This applies to class I or II recalls for class II or III devices used outside hospitals that are implanted, life‑sustaining, life‑supporting, or used a lot in children. Makers must i…
- New online device recall system: benefit, medium. If enacted, the HHS Secretary (through FDA) would publish an online recall form and a public, downloadable recall database within 2 years. The system would require maker name and contact info, the reason for the recall, the specific device and unique device identifier, and patient risk and steps to…
- New penalties for failing recall rules: benefit, medium. If enacted, the FD&C Act would add two prohibited acts. Firms that refuse or fail to send required electronic recall notices or to provide required patient notices could face FDA enforcement. The change is intended to make companies follow recall and patient‑notice rules more closely.

## Related bills

- 119-hr-7977: Energy Bills Relief Act
- 119-hr-7973: Momnibus Act
- 119-hr-3151: SHIPS for America Act of 2025
- 119-hr-3971: Domestic Workers Bill of Rights Act
- 119-hr-3069: Medicare for All Act
- 119-hr-7853: PrEP Access and Coverage Act of 2026

## Sources
- [119-hr-6594 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/6594)

## Related
- [119-hr-7977: Energy Bills Relief Act](https://policyrisk.com/legislation/119-hr-7977)
- [119-hr-7973: Momnibus Act](https://policyrisk.com/legislation/119-hr-7973)
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [119-hr-3971: Domestic Workers Bill of Rights Act](https://policyrisk.com/legislation/119-hr-3971)
- [119-hr-3069: Medicare for All Act](https://policyrisk.com/legislation/119-hr-3069)
- [119-hr-7853: PrEP Access and Coverage Act of 2026](https://policyrisk.com/legislation/119-hr-7853)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-6594 (as of 2026-04-21).