Recall roundup: FDA medical device recalls during May 2025

The FDA has historically posted press releases about Class I recalls—the most serious kind—on its medical device recall notifications webpage.

But the agency posted only one press release about one Class I recall in April. We thought that was kinda weird, but moved on. Then, it posted only one recall again in May.

Have medical devices suddenly become radically safer? Not quite. If you go to the FDA’s weekly enforcement report page or navigate to the FDA’s medical device recall database, there were other Class I recalls in April and May. They just aren’t all getting press releases, which is what we previously based this roundup on.

With that, let’s get into May’s recalls!

Car adapter confusion. Medical Depot, dba Drive DeVilbiss Healthcare, warned customers on April 11 of potentially faulty car adapters for iGo2 portable oxygen concentrator systems. The DC power supply housing can overheat and deform the plastic. Affected charger cords should be destroyed, the company said. The FDA categorized this as a Class I recall on May 9.

Concentrate concerns. Nipro Renal’s dialysate concentrate for hemodialysis may be contaminated with foreign matter, a mistake the FDA chalked up to a process control issue in a May 14 recall. The company warned users to stop using and return all affected lots on April 11.

Craniotomy kit recall. Integra LifeSciences is warning customers to quarantine certain craniotomy tools due to what the FDA has deemed poor process control, as the Codman craniotomy kit disposable perforator and perforator’s cranio-blade wire pass drill are at risk of disassembling. Integra warned customers to identify and quarantine these devices on April 11, and the FDA posted the recall on May 6. Certain lots of Medline orthopedic, general surgery, and neurological kits were also quarantined because they contained this tool and were labeled as a separate Class I recall on May 31.

Endopath echelon issues. There have been two adverse events, including one death, linked to Ethicon Endo-Surgery’s line of surgical staplers, the FDA shared in a May 20 recall. The company has gotten reports that the Endopath Echelon vascular white reload for advanced placement tip accidentally locks up in surgery, meaning it may turn on but can’t cut or staple tissue. If the device gets stuck, it can lead to serious outcomes like a life-threatening hemorrhage. The company is pointing users to instrument lockout instructions that come with the device.

Esophagogastric tube recall. The sole May recall to get a shoutout on the FDA’s medical device recall notifications page was Becton, Dickinson and Company’s (BD) correction for its esophagogastric balloon tamponade tubes after customers complained they struggled to remove the device’s plastic plugs in order to inflate the balloons. BD has updated use instructions for the tubes. Two serious injuries and a death were reported as of May 23, according to the FDA.

Eye lens issue. Bausch + Lomb has warned customers not to use certain models of its enVista intraocular lenses after increased reports of users developing toxic anterior segment syndrome, a dangerous inflammatory eye condition. FDA data indicates there have been at least 44 reported cases of this syndrome linked to Bausch + Lomb lenses since 2020, with the majority (35) reported in 2025. The FDA labeled this a Class I recall on May 2 and has attributed this to a process control issue. Bausch + Lomb said in an April 24 press release it has linked the defects to a certain vendor and ramped up inspection protocols and standards.

Infusion system issue. Baxter Healthcare Corporation sent out updated instructions for its Novum IQ LVP infusion system due to the risk of underinfusion on April 24. On May 20, the FDA deemed this a Class I recall. The recall notice doesn’t mention how many adverse events were reported or their outcomes, though the FDA database reviewing infusion pumps lists 6,800+ patients reported insufficient flow or underinfusion events since 2020 across all manufacturers, including several from Baxter’s device in recent months.

Infant ventilation risk. Adapters of certain lots of the AirLife infant heated wire circuit—which allows respiratory gas to pass between a patient and ventilator—may disconnect during setup or use, potentially pausing ventilation and seriously injuring or killing infant patients. Manufacturer Vyaire Medical told customers on April 10 they should quarantine any affected device, then destroy or return it. The FDA deemed this a Class I recall on May 9.

Pump problems. Certain CADD Solis and CADD-Solis VIP infusion pumps are under fire after manufacturer Smiths Medical sent out urgent medical device correction letters on April 10, warning of multiple different issues that warranted three Class I recall events. First came a May 5 recall based on “a potential for thermal damage” in the devices, the FDA said. Another came May 7 with a warning that pumps may trigger alarms that interrupt active infusions, potentially causing serious patient injury or death. Another May 7 recall addressed a software design flaw that could also interrupt infusions. The manufacturer updated use instructions and will issue a software update to avoid these issues in the future.

Resuscitation device pulled. On May 1, medical equipment company AirLife told customers to return or destroy certain lots of its adult manual resuscitator kit because they had been incorrectly assembled, which could lead to life-threatening consequences like hypoxia, organ failure, or death. The FDA posted this recall May 30.

Sensorized wire woes. A certain lot of Centerline Biomedical’s IOPS Guidewire 2—a wire used to guide the placement of a catheter—has issues with its coating. The company sent a notice to users with updated instructions on April 11, and the FDA deemed this a Class I recall on May 19.

Ventilator cybervulnerability. On April 7, Baxter Healthcare Corporation announced it’s permanently pulling all 4,100+ Welch Allyn Life2000 ventilators after “a cybersecurity vulnerability was discovered through internal testing.” The FDA deemed this a Class I recall on May 9.