Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.

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Caroline Catherman

Healthcare Brew delivers the latest news and trends in healthcare.

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Whether you’re a doctor checking on the devices you use, a manufacturer learning from others’ mistakes, or you just like drama, you need to know about recent FDA medical device recalls.

Every year, the FDA gets 2+ million reports of deaths, injuries, and malfunctions suspected of being linked to medical devices. The agency then issues recalls with corrections ranging from making tweaks to pulling a device off the market.

Healthcare Brew provides a monthly summary of some recent Class I recalls, the most dangerous kind.

Without further ado, here is September’s Recall Roundup!

Several components of Medtronic Cardiac Surgery’s DLP left heart ventricle catheter have been recalled because the catheters “may not retain their shape.” Medtronic told users to quarantine affected lots.

Some lots of 3M Company’s Ranger blood- and fluid-warming high-flow sets are labeled as being able to warm blood and plasma at high flow rates, when in fact the system can only keep blood and plasma appropriately warm at lower flow rates. The company has communicated the device’s actual abilities to customers and said they should follow those guidelines.

Abiomed has told users to “quarantine and cease use” of certain brands and product codes of automated Impella controllers because they could lead to decreased performance or even stop the Impella heart pump. This issue has been associated with at least one death, according to an August FDA early alert.

Medline’s medical device reprocessing program, Medline ReNewal, has added to 

 recall of certain St. Jude Medical’s Response and Supreme electrophysiology catheters. Several more Medline ReNewal’s reprocessed electrophysiology and ultrasound catheters may contain “small residual particulates” that could infect patients or cause other issues.

Dexcom has told users to update software on their continuous glucose monitor G7 and One+ iOS, watchOS, and Android apps to the latest version. Past software versions didn’t always alert users when the sensor failed.

 Olympus has told users not to use and to return affected units of its ViziShot 2FLEX (19G) endoscopic single-use aspiration needle because tips could be deformed in an undetected way. There have been 40 reported injuries and a death related to this issue as of Sept. 30, according to the FDA.

A few of Medline’s “sterile” convenience kits were never actually sterilized, and customers were told to return impacted products.

Permobil is warning users and distributors to “immediately” discontinue the use of the Max Mobility/Permobil SmartDrive MX2+ wheelchair speed control dial. There’s a risk of faulty electrical connection between the controller and the wheelchair’s motor, potentially causing the device to lose control

Mashup of hospital symbol, stethoscope, IV bag, oxygen tank, and other medical devices on orange background

Recall Roundup: September 2025

One of this month’s recalls gives new meaning to being “cold-blooded.”

As of 12:01 Wednesday morning, the US government has shut down.

The shutdown, the first since 2018, came about because congressional Democrats and Republicans 

 on a spending bill. A key line in the sand: Democratic leaders want to 

 2021 enhanced Affordable Care Act (ACA) premium subsidies while Republican leaders want to allow them to expire at the end of the year.

If they expire, premiums are expected to spike for the 24+ million people enrolled in the 

, and providers are expected to lose billions in revenue, per a recent 

 from nonprofit Robert Wood Johnson Foundation.

In the meantime, as Congress dukes it out, healthcare is going to look a little different.

For one, without a spending plan, several pandemic-era Medicare flexibilities are no longer in effect.

A 2020 waiver allowing hospitals to deliver inpatient care to Medicare patients 

As of July 2025, 400 hospitals across 142 systems and 39 states were approved to provide hospital-at-home services, according to a July American Hospital Association (AHA) fact sheet.

The Centers for Medicare and Medicaid Services (CMS) ordered all hospitals with active waivers to 

their hospital-at-home patients or return them to the hospital on Sept. 30, according to an alert on the agency’s page.

This pause may “hamper long-term progress for the hospital-at-home program,” AHA spokesperson Colin Milligan told Healthcare Brew.

Flexibilities that reimbursed telehealth care for Medicare beneficiaries at their homes regardless of where they lived also expired Oct. 1, despite 

 must take telehealth appointments from locations such as a provider’s office or skilled nursing facility within a rural health professional shortage area, a federal telehealth demonstration project, or in a county that isn’t in a metropolitan statistical area.

Exceptions are made for behavioral health and substance use treatment and for people with some other medical conditions such as kidney failure, according to the Department of Health and Human Services (HHS).

Some providers and hospital systems have reportedly started blocking these patients from scheduling visits, though 

 are still providing telehealth care in the hopes of later retroactive payment, according to an Oct. 1 letter from the American Telemedicine Association’s advocacy arm, ATA Action.

 urged President Trump and Congress to extend the flexibilities and enact a retroactive telehealth reimbursement program so those medical professionals can be reimbursed.

“Medicare patients woke up this morning without telehealth coverage for the first time since the pandemic, five years ago. Our healthcare services are regressing, falling woefully short for millions of patients in need,” Kyle Zebley, executive director of ATA Action and SVP of public policy at ATA, said in an Oct. 1 press release.

 41% (32,460) of staff “as of day two of a funding lapse.” About 59% (47,257) will stay on to conduct essential activities such as monitoring for disease outbreaks, conducting crucial research and clinical tasks, and reviewing drug and medical devices.

Medicare and Medicaid payments will continue, and CMS has enough cash on hand to fund Medicaid through Q1 2026, according to a CMS contingency 

. But some survey activity, contract oversight, and beneficiary casework has been paused.

 new drug applications during the shutdown, according to the agency’s contingency plan.

an illustration of the US Capitol building being unplugged

What a government shutdown means for healthcare

New drug submissions, Medicare coverage of telehealth, and hospital-at-home are all paused. 

Every year, the FDA gets 2+ million reports of deaths, injuries, and malfunctions suspected to be linked to medical devices.

Sometimes, these incidents are one-offs. But they can also be a sign of a bigger problem. In these cases, companies warn providers to change how they use these devices or stop using them altogether. The FDA categorizes many of these incidents as recalls, which range from Class III (least dangerous) to Class I (most dangerous).

Whether you’re a doctor double-checking if the devices you use are affected or someone merely curious about how multimillion-dollar technological innovations can go wrong, we’re keeping you informed on some of those Class I recalls here in our monthly (noncomprehensive) series.

Boston Scientific has issued guidance on reducing the risk of air embolisms when using its Watchman access systems. As of July 30, Boston Scientific reported 120 serious injuries and 17 deaths linked to this issue, according to an FDA release current as of Aug. 6.

 The Plum Duo Infusion System’s user interface may stop responding in certain circumstances, ICU Medical warned customers in a letter that included troubleshooting instructions.

Some handles on Flexicare Medical’s BritePro laryngoscopes aren’t illuminating like they’re supposed to. The company told users to check if their device handles light up and return them if they don’t.

Abbott has informed customers some power cords for mobile power units that connect to its HeartMate blood pump may not properly lock into place, potentially disconnecting the power source from the pump.

Medline’s medical device reprocessing program, Medline ReNewal, says some lots of its reprocessed versions of St. Jude Medical’s Response and Supreme electrophysiology catheters may be contaminated with “small residual particulates.” Medline is asking customers to notify the company and quarantine any affected lots.

Boston Scientific is removing some batches of the carotid Wallstent monorail endoprosthesis closed cell self-expanding stent and accompanying pieces, the company said in a letter after providers reported it was difficult to withdraw the stent delivery system.

 This one is simple enough: The Microbore extension set with 0.2 micron filter has a label saying it includes an air-eliminating filter. It doesn’t. It has a filter, but not an air-eliminating one, B Braun Medical said in a letter to users.

Certain serial numbers of printed circuit boards for the Hamilton-C6 ventilator need replacement. The boards have a defect that could cause the ventilator to fail before it starts up or even interrupt ventilation, according to Hamilton Medical AG.

Recall Roundup: August 2025

Paging all providers: Change how you use these devices, stat!

The number of FDA-cleared artificial intelligence-enabled medical devices has 

 in 2023 to 1,247 as of Aug. 28, according to the federal agency’s 

And healthcare systems are getting on board. In a 

, about 88% of 233 health system executives said their system uses AI.

Though only a small percentage have been recalled, 60 AI-enabled devices racked up 182 recorded recall events as of November 2024, according to an Aug. 22 JAMA 

Throughout these recalls, there was a consistent thread: Publicly traded companies’ devices (about 92%) were recalled more frequently than private companies’ devices (53%).

“That was really something we were surprised by because we were thinking public companies probably have better risk management,” Tinglong Dai, Bernard T. Ferrari professor at the Johns Hopkins University Carey Business School and one of the paper’s authors, told Healthcare Brew.

The paper theorizes public companies could feel pressure from investors to put out devices as quickly as possible, perhaps not giving them time for more thorough research.

“Investors, they want to see year after year you have new AI devices cleared by the FDA, you have AI devices being rolled out among healthcare providers, so the pressure itself might have contributed to the recalls,” Dai said. 

There were several main reasons for the recalls—a designation that ranges from a quick software update to total market removal—with 109 recalled due to diagnostic or measurement errors, 44 for a functionality delay, 14 for physical hazards, and 13 for biochemical hazards.

“If you have a misdiagnosis, obviously the entire healthcare delivery could be subject to risk because wrong diagnosis means that you could also have the wrong treatment,” Dai said.

The research letter identified another pattern, too. The majority (40% from the private companies, 78% from established public companies, and 97% from smaller public companies) of the recalled devices weren’t clinically validated before they were approved.

 are given the greenlight through the FDA’s 510(k) pathway, which clears a device if it proves it is “substantially equivalent” to a previously cleared device. Clinical data is not normally required to get an OK via a 510(k), as opposed to other clearance processes.

This is something health systems and providers should keep in mind when deciding 

“From the user’s perspective, I think it’s extremely important to understand…the difference between reported performance and real-world performance,” he said.

Even AI programs with strong premarket clinical data “frequently” perform worse in diverse real-world clinical settings, according to a March 2025 

This is one of the reasons the American Medical Association uses the term “augmented intelligence” rather than “artificial intelligence,” according to the organization’s website. AMA 

 says that AI is not supposed to call the shots or operate without oversight by a human healthcare professional.

A Department of Health and Human Services spokesperson told Healthcare Brew the agency “is not able to confirm” the numbers cited in the JAMA study, but “remains committed to ensuring patients have access to safe and effective medical devices, including those enabled with AI.”

In addition to general device software validation and safety requirements, the agency released 

 in January specifically for AI-enabled devices, like what data and documentation is needed to show safety and effectiveness.

Tinglong Dai’s title has been clarified.

Pill capsule with tech system inside, slightly open, and a honeycomb-like web in the background

Over 90% of recalled AI-enabled medical devices were from public companies

Though only a few AI-enabled devices have been recalled, patterns are emerging.

Are you curious about all the ways multimillion-dollar medtech can go wrong?

If so, welcome to Recall Roundup, where we keep our eyes on the FDA’s recent medical device recalls.

First, a company takes action, then the FDA categorizes that action as a recall from Class III (least dangerous) to Class I (most dangerous) and summarizes those recalls in weekly enforcement reports, which also include early alerts for things that may be recalled later on.

Without further ado, below is a noncomprehensive list of recent Class I recalls.

Getinge subsidiary Maquet Critical Care AB has updated instructions for all of its Servo-u, Servo-n, and Servo-u MR ventilators due to an error that could result in a difference between the volume of oxygen delivered and the volume displayed.

Edwards Lifesciences has pulled several lots of its OptiSite arterial perfusion cannula, a device used during cardiopulmonary bypass procedures, as there have been a few instances where a wire separates from the device.

Medtronic has pulled certain lot numbers of the Bravo CF capsule delivery device, which delivers a capsule that monitors the pH of a patient’s esophagus. But a misapplied adhesive on the delivery device sometimes keeps the capsules from properly and safely attaching, the FDA reported.

Abiomed updated instructions for the controller to its Impella heart pump. The manufacturer said sometimes the control doesn’t detect the pump when it connects.

AirLife and Vyaire are pulling AirLife infant heated wire circuits, used to support ventilation, because they can potentially disconnect unexpectedly, according to the recall.

Baxter Healthcare Corporation gave customers new instructions for its Novum IQ large volume pumps after reports of over and underinfusions of fluids.

Certain lot numbers of Intersurgical’s i-view video laryngoscope are being pulled because of a potential for the devices’ batteries to become depleted, resulting in faulty performance, the FDA reported.

 An optional component for machines that lift patients up might not attach properly, risking patients falling to the ground. Baxter Healthcare Corporation warned consumers to not use the part.

 Some versions of AirLife’s Broselow Rainbow Tapes—a color-coded tape that provides treatment recommendations based on a child’s height and weight—have incorrect measurement values, the company reported in its recall.

Correction 08/05/2025: This story has been updated to clarify that Baxter Healthcare Corporation

gave customers mitigating instructions for using its

recalled Novum IQ large volume pumps; the company did not warn users to discontinue use, as stated in the original story.

Recall Roundup: FDA medical device recalls in July 2025

Recalled devices include infusion pumps and an esophageal pH monitoring capsule.

Sarepta Therapeutics is laying off 36% of staff—500 employees—a move expected to be “substantially completed” by the end of Q3, it announced in a July 16 

As part of these changes, the company is scrambling its C-suite:

The company is terminating Dallan Murray, EVP and chief customer officer, though he will remain a consultant through January 2026.

Ian Estepan, former EVP and CFO, is now president and chief operating officer.

Former president and CEO Douglas Ingram will solely be CEO from now on.

Ryan Wong has taken over Estepan’s old positions.

Louise Rodino-Klapac is now the company’s president of R&D and technical operations. She was previously EVP and chief scientific officer, and headed R&D.

Sarepta will also add a black-box warning—the most serious kind—for acute liver injury and failure for Elevidys, per the FDA’s request. Elevidys, the company’s most profitable product, is the only FDA-approved gene therapy for deadly muscle-wasting disease Duchenne muscular dystrophy.

Elevidys has been somewhat controversial since its June 2024 approval.

Then-director of the Center for Biologics Evaluation and Research Peter Marks overruled his staff to give the drug full approval for ambulatory patients ages 4+ and accelerated approval to nonambulatory patients.

This happened even though the FDA’s clinical and clinical and clinical pharmacology review team wrote it had “no satisfactory data to support effectiveness claims for all ages and for nonambulatory patients,” 

In the year since the drug’s approval, two nonambulatory patients taking Elevidys died of acute liver failure. One case was disclosed in 

After the second death, Sarepta announced it was pausing shipping Elevidys to nonambulatory patients.

Sarepta added in its July 16 update that an internal expert committee has devised an “enhanced immunosuppressive regimen” for nonambulatory patients to take in order to reduce their chances of acute liver failure.

The company plans to submit that to the FDA and start gathering evidence on how to safely resume the treatment in patients who can’t walk.

In total, more than 900 people have taken the drug worldwide, according to the company.

the Sarepta Therapeutics company logo is seen displayed on a smartphone screen.

Sarepta to cut 36% of staff, add black-box warning to Elevidys

The layoffs come after two deaths of patients who had taken its most profitable product, Elevidys. 

Are you curious about all the ways that multimillion-dollar medtech can go wrong?

If so, you’re in the right place!Welcome to Recall Roundup, a noncomprehensive roundup of recent FDA Class I recalls—the most severe and potentially life-threatening kind. Recalls range from correcting an issue to removing a device from the market altogether.

Blood products administration set recall.

 Fresenius Kabi has pulled an incorrectly assembled line of its Ivenix LVP Blood Products Administration Set. If used, patients could be infused with unfiltered blood.

Cook Medical wants customers to return certain Cook Beacon Tip 5.0 Fr angiographic catheters because the tip is at risk of detaching.

Medline told customers to stop using and destroy certain lots of neonatal and pediatric convenience kits that contain recalled Smiths Medical endotracheal tubes. The company said the tubes are too small and could cause underventilation.

Some Dexcom G6, G7, One, and One+ glucose receivers with certain serial numbers may have receivers that weren’t correctly assembled and should be returned.

Zyno Medical asked customers to stop using certain lots of its Z800WF Infusion System because “unreleased software versions” were installed “without verification or validation.”

Medtronic is asking customers to replace certain models of its Newport HT70 series ventilators and control boards. They have defects that can cause the ventilator to shut down during use or otherwise malfunction.

assortment of various medical devices around a teal healthcare symbol

FDA