MGood Recalls and Bad Recalls
In a recent piece, Medical device recalls in 2026: 5 things supply chain leaders should know, June 10, 2026, Becker’s Hospital Review’s Ella Jeffries wrote about the unfortunate state of affairs at FDA: “Device recalls aren’t slowing down — and the FDA has acknowledged it doesn’t have the capacity to manage the current volume. For supply chain leaders already absorbing cost pressure, tariff uncertainty and a tight labor market, the practical question isn’t whether a recall will hit their system. It’s whether they’ll be ready when it does”. In an earlier Becker’s article from December, 2025, Jeffries reported on a recent GAO report addressing delays at FDA: “The GAO report said the FDA relies almost entirely on manufacturers to voluntarily initiate recalls, about 900 per year, and lacks the staffing needed to monitor them effectively. FDA staff told the GAO they often can’t read status reports or track how many patients have been notified.” This month, Jeffries added that the recent GAO report found “[o]f the nearly 4,000 recalls initiated from 2020 to 2024, 62% were still ongoing at the time of the report. Some stakeholders told GAO the delays directly affect patient care”.
Ella Jeffries June 2026 piece mentions Boston Scientific’s pacemaker recall (after 4 deaths and 2,500 injuries); Abbott’s glucose sensor recall (after 7 deaths and hundreds of injuries); J&J MedTech’s neuro device recall (after 1 death and 4 injuries); Medtronic’s heart vent catheter recall (after several injuries); AbioMed’s heart pump recalls(after several injuries). These are all serious (high-severity) 2026 recalls.
Recalls are going to happen, they are unavoidable. But there are good recalls and bad recalls: It is all about how they are handled by the reporting firm and by the authorities that oversee them – FDA. Lack of capacity at FDA to perform this role is unacceptable, both in terms of managing patient risk and in terms of healthcare supply chain resilience and economics.
Jeffries’ piece also mentions that several recent recalls have been associated with Medline’s catheter reprocessing company. Several of these recalls are Class One recalls, such as for example a recall of intracardiac echocardiography (ICE) catheters in July, which described the recall reason as devices “… containing small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.” As a reminder, a Class One Recall is the most serious level of recall, indicating “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” It is important to note that reprocessing is a successful practice because clinicians, service line managers and hospital leadership believe in the safety and functionality of reprocessed products. In general, single-use device reprocessing is a safe, FDA regulated practice, and there is no reason to believe that the recent large number of Medline recalls reflects a poor safety record of the reprocessing industry in general.
Let’s take a look at the timeline to understand what FDA delays mean: On July 14, 2025, Medline sent affected customers an “Urgent Medical Device Recall” communication. On August 13, 2025, Medline sent an updated communication to previously notified and additional customers containing additional affected product. In a December 22, 2025 letter to affected customers, Medline stated that specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates, and FDA ultimately reports this on March 5, 2026. Last week (June 18, 2026), FDA then published another expansion of the recall, which now covers 9 different device families and 134 lot numbers.
I take no pleasure in seeing a competitor go through such a large number of recalls, because recalls tarnish the reputation of the entire industry. Further, Medline did everything they could to inform their customers, and as of June 16, 2026, Medline has not reported any serious injuries or deaths related to this issue. This is not the problem - the delay in FDA’s reporting is a problem. Additionally, the large number of high-severity recalls from medtech companies like Abbott, J&J MedTech, Boston Scientific, Medtronic, AbioMed and Medline IS a problem: Are medtech companies sufficiently committed to ensuring a constant supply of high-quality medical devices? Packaging glitches happen, mislabeling happens, but these are all high-severity recalls with patient deaths associated in some cases. In the case of Medline, you could argue that residue in the devices indicates that the company failed to clean or inspect the device, the most basic task of a medical device reprocessor.
From a healthcare supply chain perspective, recalls mean supply chain disruptions and cost increases. Most hospital supply chains have been designed to minimize costs – not to handle supply chain disruptions (single-vendor contracts are a good example). This means that when a recall occurs, the hospital has to scramble to find alternative suppliers – at a higher costs. Becker’s has reported that medical supply chain costs are expected to rise by 2.41% in 2026. Reimbursement is not increasing at the same rate, so ultimately, the large number of high-severity recalls will increase the already intense pressure on the hospital’s bottom line – and affect the hospital’s ability to provide timely care to its patients.