Top Medical Device Recalls and Warnings of 2025 Resulting in Lawsuits and Investigations

Warnings over ByHeart infant formula, Depo-Provera, Impella heart pumps, Ocaliva and Oxbryta are leading to a growing number of lawsuits against manufacturers moving into 2026.

Throughout 2025, health regulators and manufacturers announced numerous recalls affecting defective medical devices and medications that put individuals at serious risk of injury and death.

Several of the most serious recalls involved drugs and medical devices that exposed individuals to an unreasonable risk of severe health complications. As a result, manufacturers are facing lawsuits from former users seeking compensation for injuries, long-term harm, and, in some cases, the loss of loved ones. Many of these injuries, plaintiffs allege, could have been prevented with proper testing, clearer warnings and honest marketing.

In this featured post, AboutLawsuits will examine the most significant drug and medical device warnings and recalls, the litigation that followed, their regulatory history, the risks posed to patients and consumers, and how these cases are expected to move forward in the coming year.

Depo-Provera Brain Tumor Warnings

Depo-Provera (Depot medroxyprogesterone acetate) was originally approved by the U.S. Food and Drug Administration (FDA) in 1992, as a long-acting hormonal contraceptive that requires a quarterly injection of the synthetic progestin medroxyprogesterone acetate. Tens of millions of women have repeatedly been injected with the birth control shot over the last several decades, believing advertisements that claimed it is safe and effective.

However, in March 2024, a study published in The BMJ found that taking synthetic progestogens for more than one year increases a person’s risk of developing intracranial meningiomas, commonly referred to as brain tumors. The most pronounced brain tumor risk was linked to the side effects of Depo-Provera, a commonly used birth control injection, which increased the risk by 5.6 times, the researchers determined.

Meningiomas are a type of rare brain tumor that only occur about 10 times per hundred thousand person-years. They typically are not cancerous and grow slowly, but account for 40% of central nervous system tumors. Even when not cancerous, they can put pressure on the brain, leading to potential cognitive problems, vision loss and death. In many cases they require surgical removal or other interventions to decompress the tissue, yet in some cases their positions, while not harmful, are too dangerous for brain surgery, and must be monitored for life in case they grow to be a serious threat.

Since 2022, women in both Canada and the European Union have benefited from Depo-Provera brain tumor warning labels. However, that warning was withheld from women in the U.S. until this month, when the FDA approved a new Depo-Provera meningioma label warning, including data on risks of meningiomas and strongly recommending doctors monitor patients receiving the birth control injections for signs of developing brain tumors. It calls on patients to immediately discontinue Depo-Provera if a meningioma is diagnosed.

Depo-Provera Meningioma Lawsuits

To date, more than 2,100 Depo-Provera brain tumor lawsuits have been filed by women throughout the U.S., alleging that the drug makers knew or should have known about the potential brain tumor risks for years, yet failed to adequately warn users and doctors, depriving them of critical information that could have prevented the development of meningioma.

The U.S. Judicial Panel On Multidistrict Litigation (JPML) has centralized all Depo-Provera lawsuits brought throughout the federal court system in the Northern District of Florida, under U.S. District Judge M. Casey Rodgers who is overseeing coordinated discovery and pretrial proceedings, and has stated she seeks a swift resolution to the litigation. To help the parties gauge the relative strengths and weaknesses of their claims, and promote potential Depo-Provera meningioma settlements, Judge Rodgers has instructed the parties to prepare a group of five “pilot” cases for early trial dates, which will give them a chance to see how juries respond to evidence and testimony likely to be repeated.

Judge Rodgers is expected to rule on a series of motions throughout 2026, preparing for the first Depo-Provera pilot trials to go before juries by the end of 2026 or in early 2027. Those motions will include ruling on whether plaintiffs can prove general causation, and which expert witnesses will be allowed to testify before juries in order to prove or disprove the link between the “Depo Shot” and a large variety of brain tumors, including:

Lawyers are still investigating new, potential Depo-Provera brain tumor side effect lawsuits against Pfizer and generic manufacturers for women throughout the United States who have developed injuries that could have been prevented.

ByHeart Formula Recall

In early November 2025, federal and state health regulators began to track an outbreak of infant botulism cases across multiple states. Investigators eventually traced the illnesses back to a potential source, announcing a ByHeart formula recall as a result. While the initial action only included two batches of the formula, an expanded recall was announced just days later, pulling all batches of ByHeart Whole Nutrition Infant Formula Cans and Anywhere Packs from the U.S. market.

A recent update by the CDC indicates the ByHeart infant botulism outbreak sickened at least 51 infants in 19 states. Case reporting has been expanded to include a date range from the product’s release in March 2022 until December 2025. All infants involved have been hospitalized.

FDA inspectors have found problems with the company’s manufacturing processes for years, including at its Reading, Pennsylvania facility in the summer of 2022, when cronobacter sakazakii was discovered in the processing area of the plant. Several weeks later, the same contaminants were found in a can of finished formula, yet FDA investigators reported that the company claimed the laboratory made a mistake and that there was no contamination.

Investigators also discovered mold in sources of clean water, dead insect corpses in food production areas and roof leaks. These factors led to a ByHeart cronobacter recall in December 2022.

ByHeart Formula Recall Lawsuits

Since the infant botulism recall, a number of ByHeart formula recall lawsuits have been brought by parents whose children were sickened, seeking compensation for their injuries. The claims allege the company allowed contaminated formula to enter the marketplace and failed to prevent exposure to Clostridium botulinum, resulting in severe illness, emergency hospitalization and lasting health concerns.

Several of the lawsuits involve parents whose children required hospitalization after developing symptoms of infant botulism, including muscle weakness, feeding difficulties and respiratory distress. The complaints allege the manufacturer failed to adequately test, monitor or safeguard its products before they were sold to consumers.

In addition, the company also faces ByHeart class action claims, seeking to represent all consumers who purchased the recalled formula, regardless of whether their children became ill.

Parents who believe their children developed botulism after consuming ByHeart formula may be eligible to file a claim. To find out if you qualify, submit information about your potential case for review.

Impella Heart Pump Recall

The Abiomed Impella pump is a cardiac support device designed to assist patients undergoing severe heart problems. The pencil-sized blood pump is inserted into the heart’s left ventricle through the femoral artery. It draws blood from the ventricle and expels it into the ascending aorta, ensuring oxygen-rich blood circulates throughout the body.

Impella devices are commonly used during cardiac procedures or when the heart requires support to maintain adequate blood flow, such as during high-risk percutaneous coronary interventions (PCI) or in treating cardiogenic shock, a condition where the heart suddenly fails to pump enough blood.

Since its introduction, the Impella has been the subject of numerous recalls and safety warnings citing malfunctions, such as valve perforations, many of which have resulted in patient deaths. In 2019, officials stated that while initial clinical trials reported a 73% survival rate among patients, real-world interim results from 2019 showed only a 28% survival rate among Impella patients transitioning to long-term therapy.

In June of 2023 a recall was issued for Impella 5.5 with SmartAssist pumps due to purge fluid leaks that led to device malfunctions, heart valve damage and a heightened risk of severe injuries, with 179 related complaints. Finally, in March 2024, the FDA announced a Class I recall for Abiomed’s Impella Left Sided Blood Pumps following at least 129 reports of serious injuries and 49 deaths linked to heart perforations, caused by the pump catheters piercing the wall of the left ventricle in the heart.

Impella Heart Pump Lawsuits

Given the growing number of undisclosed Impella side effects resulting in serious injuries and fatalities, and new evidence that suggests Abiomed may have known about such risks since January 2018, lawyers are now investigating Impella heart pump lawsuits.

Lawsuits are being investigated due to the manufacturer’s potential failure to disclose known adverse events, which could have prevented patients and doctors from making fully informed decisions about the safety of the pumps, possibly leading to additional injuries and deaths.

Financial compensation may be available through an Impella heart pump lawsuit for individuals who suffered any of the following complications after receiving the heart pump:

Ocaliva Recall and Warnings

Ocaliva (obeticholic acid) is an Intercept Pharmaceuticals drug approved in 2016 by the FDA for the treatment of primary biliary cholangitis (PBC), a rare autoimmune disease that slowly destroys the liver’s bile ducts. PBC causes the ducts to become inflamed and eventually collapse, leading to liver damage that can eventually result in cirrhosis.

The drug was approved through the FDA’s accelerated approval program, which allows it to be marketed for use in combination with ursodeoxycholic acid (UDCA) or as a second-line therapy for those who failed to adequately respond to UDCA alone, aiming to slow disease progression and improve liver function over time. 

However, very soon after the drug was approved, the FDA warned of the risk of Ocaliva dosing errors in September 2017, followed by a black box warning in February 2018 that tightened dosing instructions, added new monitoring requirements and expanded safety warnings. In December 2024, the agency warned that Ocaliva was linked to a 377% higher risk of liver transplant or death, including 19 fatalities and 11 severe liver injuries reported within 18 months of Ocaliva hitting the market.

The agency found that in a study of 81 Ocaliva patients considered to have a lower initial risk of liver injury, seven ultimately required a liver transplant, while a transplant was needed by only one of the 68 patients given a placebo. That single placebo patient had switched to Ocaliva for two years before needing the transplant, suggesting Ocaliva side effects may have still played a role in the injury.

In September of this year, Intercept Pharmaceuticals withdrew Ocaliva from the market after federal regulators concluded that its risks outweighed its benefits. According to FDA Adverse Event Reporting System (FAERS) data, the agency has received at least 6,624 adverse event reports, with about 3,000 of those filed in the first couple years the drug was on the market. To date, the FDA has linked 367 deaths to Ocaliva adverse event reports.

Ocaliva Recall Lawsuits

It is expected that the Ocaliva recall and hundreds of patient deaths will result in an influx of Ocaliva lawsuits filed in 2026.

As a result, Ocaliva injury lawyers are now investigating product liability claims against Intercept Pharmaceuticals for marketing the drug for PBC treatment and pushing it through the FDA’s accelerated approval process before it had been fully tested.

Ocaliva lawsuits are being reviewed for individuals who took the medication and later experienced liver injury, liver failure or death. Claims are expected to allege that the manufacturer failed to warn the medical community and patients about the risks of Ocaliva liver injuries, while misleading the FDA about the drug’s safety.

Oxbryta Recall

Oxbryta (voxelotor) was first introduced in 2019 by Global Blood Therapeutics, which was later acquired by Pfizer for $5.4 billion in 2022. It was the first oral medication specifically approved to treat sickle cell disease, which is a lifelong blood disorder that affects protein in the blood, causing blood cells to break down and die due to a lack of oxygen.

The Oxbryta tablets were quickly adopted by patients across the nation, as a convenient alternative to existing sickle cell disease treatments, which were largely limited to intravenous drugs, blood transfusions or bone marrow transplants.

However, after just five years on the market, Pfizer issued an Oxbryta recall in September 2024, warning that a number of sickle cell patients had experienced vaso-occlusive crises (VOCs), which are severe and painful episodes caused by the blockage of blood flow due to the clumping of sickle-shaped red blood cells in blood vessels.

The FDA’s Adverse Events Reporting System has linked Oxbryta side effects to more than 300 deaths since 2020.

Oxbryta Lawsuits

Shortly after the recall, the first product liability lawsuit was filed in California, followed by several more Oxbryta lawsuits in the following months, alleging that the manufacturers were aware of the risk of VOC side effects since at least 2020, yet placed profits ahead of patient safety by keeping the information from the public.

In the latter part of 2025, potential settlements had been announced for an Oxbryta wrongful death lawsuit, and negotiations have been held for potential settlements for an Oxbryta class action lawsuit, suggesting Pfizer is keen on resolving the litigation quickly.

Lawyers continue to pursue Oxbryta recall lawsuits for individuals who were prescribed the drug for the treatment of sickle cell disease and developed any of the following side effects, injuries or severe complications:

• Death
• Stroke
• Severe pain and swelling
• Vaso-occlusive crises (VOCs)

Medical Device and Drug Recall Lawyers

If you or a loved one have been impacted by any of the recalled medical products or drugs, submit information about your potential claim for review by a personal injury product liability lawyer to determine if you may be eligible for a product liability lawsuit settlement.

Lawyers provide free consultations to help determine if individuals may be eligible to file a claim, and there are never any fees or expenses unless a settlement is obtained in the case.

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