Recalls: They Aren’t Over ‘Til FDA Says So, But Who Knows When That Will Be

On December 8, 2025, the Government Accountability Office (GAO) sent a report to Senators Richard Durbin and Richard Blumenthal in response to the Senators’ request for GAO to review FDA’s medical device recall process. At a high level, the findings are not surprising—FDA’s staffing is insufficient to conduct adequate oversight of medical devices recalls, and FDA’s legal authority limits what it can mandate of manufacturers who carry out voluntary recalls. GAO recommends:

HHS work with FDA: 1) to conduct workforce planning for device recalls, and 2) to assess and seek, if needed, additional authority for manufacturer-initiated recall strategies.

GAO stated that it made these recommendations to HHS, which concurred with the first, and is still considering the second.

1.  Workforce Planning

On the first point, it is notable that GAO’s report examines recalls overseen by FDA from FY2020 through FY2024—prior to the drastic agency reductions-in-force and departures that took place this year. It seems reasonable to assume that if FDA staff resources were previously constrained in their ability to conduct necessary recall activities, such constraints are almost certainly now further amplified by the action of the current administration with the significant voluntary and involuntary departures that have occurred in 2025.

The GAO report covers many different areas, from the process for conducting recalls to how FDA classifies recalls (Class I being highest risk, Class III lowest), interactions between FDA and industry during the conduct of a recall, and areas in which FDA has expressed an inability to oversee all aspects of a recall. While we do not intend to address all areas covered in the 49-page report, we will highlight a few notable takeaways.

a)  Device recalls are more voluminous and more multifaceted than drug or biologics recalls in many ways, adding to the complexity of FDA oversight.

The GAO report notes that “[i]n any given year, there are more device recalls than biologics and drug recalls combined.” This is not necessarily surprising, given how medical devices function as compared to drugs and biologics. For drugs and biologics, recalls are almost exclusively focused on safety issues associated with use of the product. For medical devices, recalls may be initiated for malfunctions even if those malfunctions have not caused harm, and even if the likelihood of harm is minimal. Furthermore, as noted in the report, medical devices undergo “rapid improvements and continuous enhancements” compared to biologics and drugs, making medical device oversight more challenging. The report notes that this results in FDA needing to process “a large volume of medical device recalls with limited time, insufficient staffing levels, and information technology database systems that require extensive manual data entry.”

b)  FDA staff acknowledge certain areas of lapsed recall oversight due to inadequate staffing.

The report calls out specific areas of recall oversight that are not currently undertaken due to staff shortages, including reviewing manufacturer Recall Status Reports and conducting in-person recall audit checks. According to the report, “Officials said they often forgo these activities because they must shift staff’s priorities to focus on the highest risk recalls (class I) and on the earlier stages of the recall process (initiation and classification).”  Consistent with this sentiment, as we have previously reported, and as is mentioned in the GAO report, CDRH recently implemented its Early Alert Communications program for potentially high-risk device recalls in an effort to inform the public in a more timely manner about potential risk associated with certain marketed devices.

c)  Termination of a recall by FDA is not a high priority and many months, if not years, can pass between a manufacturer’s request for recall termination and FDA’s issuance of a termination notice.

According to GAO, recall termination “is on the ‘back burner’ due to limited resources.” GAO’s investigation found that 74% of recalls across FY2020-2024 exceeded FDA’s policy of terminating a recall within three months of receiving a termination request from a manufacturer.

From a patient and provider perspective, these delays can sow confusion. As discussed in the report, if the recall has not been terminated, patients and providers may continue to believe that there is an ongoing problem with a particular product, or that FDA has not been satisfied with the recall activities, when the reality may simply be that FDA has not gotten around to it. This can also create problems during mergers and acquisitions, as a buyer may be concerned about a target’s open recall, even if the recall has been resolved adequately but FDA has not issued the termination notice.

d)  Communication between FDA and industry regarding execution of a recall is mutually inadequate.

Neither FDA nor industry is entirely happy with communications during the course of a recall. Interviews with industry trade groups indicate that FDA’s classification process is a “vacuum,” making it difficult for industry to ascertain the factors that FDA considers warrant a high-risk (Class I) classification. Additionally, FDA’s focus is primarily on the earlier recall discussions, leaving industry in the dark when it comes to closing out a recall.

From the FDA perspective, it cannot mandate that manufacturers take certain steps during a recall, which can lead to frustration on FDA’s part when a manufacturer fails to do what FDA is recommending. While it is true that FDA cannot mandate certain actions be taken, in our experience, in most instances the manufacturer will work with FDA to find a mutually agreeable solution to an FDA request. Additionally, FDA has the ability to issue its own press release about high-risk recalls, so while it may not be able to mandate specific activities, FDA does have leverage to influence what is or is not communicated to customers and the public.

e)  Though FDA has taken steps to improve transparency related to potential device risks, it is not clear how the agency will improve the areas that are currently lacking oversight given the reductions in force.

Despite its smaller workforce, CDRH has this year put additional focus on medical device recalls. While the Early Alert program has resulted in the public becoming aware of potential issues earlier, it is not clear the extent to which this program will ultimately affect other challenges identified in the GAO report, particularly with respect to communications toward the end of a recall. To the contrary, this pilot program emphasizes industry’s concern that FDA is far more engaged at the early stages of a recall than it is at the end.

2.  Legislative Authority

GAO also recommended that FDA assess whether it needs additional authority to require manufacturers to implement certain recall strategies.  In situations when FDA and the manufacturer disagree – e.g., about language in the customer letter, or whether to conduct a removal or whether a labeling change is adequate – GAO states that FDA “should have clear and sufficient authority” to conduct effective oversight over recalls.  FDA said it would consider this recommendation, noting that there are potentially more resources required to implement these new authorities, but acknowledging that having the ability to require manufacturers to use certain language could streamline review time for recall communications.  There is legislation proposed by the requestors of the GAO report, among others, to modernize FDA’s recall notification authority; as of the date of this blog post, the House and Senate bills are working their way through the committee review process.

*****

FDA and industry both can undoubtedly benefit from improved communications, increased transparency, and a collaborative approach across the entirety of the recall process. Given the staffing shortages at the agency, it remains to be seen whether or to what extent CDRH will be able to adopt GAO’s recommendation to conduct adequate and appropriate workforce planning for improved recall oversight.