> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# GAO Probing FDA Ventilator Recall Actions
- URL: https://www.fdaweb.com/gao-probing-fda-ventilator-recall-actions/
- Published: 2024-01-17T12:00:00.000Z
- Updated: 2026-09-14T14:20:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156149

At the request of Sens. **Dick Durbin** (R-IL) and **Richard Blumenthal** (D-CT), the Government Accountability Office (GAO) will look into FDA’s role and actions in oversight of medical device recalls, and especially the Philips Respironics recall of breathing machines. The *Pittsburgh Post-Gazette*, which worked with *ProPublica* on reports detailing FDA’s work during the Respironics recall, [says](https://www.post-gazette.com/business/healthcare-business/2024/01/17/congress-fda-philips-breathing-machines-durbin-blumenthal/stories/202401160139?ref=fdaweb.com) the senators cited those [reports](https://www.fdaweb.com/update-gao-device-recall-oversight-report-senators/) in their request to GAO.

In a statement last week, FDA said it “welcomes the opportunity for GAO review of the agency’s oversight of medical device recalls.” GAO told the *Post-Gazette* it had accepted the senators’ request for an inquiry.

“It’s clear from the Philips case that information about patient harm was known for years and not properly shared or addressed,” Durbin said in a statement. “We must ensure there is adequate oversight on medical device manufacturers so that Americans know the potential risks and can make informed decisions with their healthcare providers.”

Durbin and Blumenthal told GAO they need more information about FDA’s oversight of the medical device industry, including how it ensures that companies initiate recalls and what happens when manufacturers fail to comply. A similar GAO probe in 2011 called for changes to better protect patients, the story says. It says safety advocates have said a new investigation is badly needed and long overdue.

In 2022, the *Post-Gazette* says, FDA received three million reports about malfunctioning devices, about 30 times more than in 2005\. Nearly one-third described injuries and deaths, it says.

The story says device safety advocates say GAO should review whether FDA is regularly using information in health records, insurance claims, medical device registries, and other sources to improve its ability to track dangerous products.

Former FDA public health analyst **Madris Kinard** told the newspaper FDA should do more to ensure the safety of medical devices before they are marketed and sold. She pointed to the 510(k) approval pathway and said FDA should investigate whether the products that are already on the market have had any safety issues before they can be cited as predicates in 510(k) approvals. “Simply getting a new device to market to me isn’t innovation,” she said. “Innovation is only good if it’s helping the patient.”