BioZorb Lawsuit Explained: The Recall, the Injuries & the 2026 Settlement

Common Questions About the BioZorb Lawsuit

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BioZorb was a small implantable marker placed in the breast after a lumpectomy. Its plastic framework was designed to dissolve over a year or longer, while permanent titanium clips remained to mark the surgical site.

For many patients, it didn’t dissolve, and the complications that followed led to a Class I FDA recall and a wave of BioZorb lawsuits against the manufacturer, Hologic.

By early 2026, the parties reached a global settlement intended to resolve the substantial majority of the BioZorb litigation. Our blog explains what the device was, the reported injuries, the BioZorb recall, how the lawsuits against Hologic unfolded, and where things stand now.

If you were not included in the settlement, you should not assume it automatically ended your right to bring a separate claim. Your legal options depend on your case and the statute of limitations in your state.

If you have questions regarding a defective medical device lawsuit, contact Bernheim Kelley for a free case review.

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The Real Deal: Current Status

The BioZorb litigation entered a formal settlement agreement in January 2026 after approximately 200 plaintiffs brought claims against Hologic. The settlement was intended to resolve the substantial majority of those cases, while the individual payment amounts remained confidential.

• Hologic recalled all unused BioZorb and BioZorb LP markers in October 2024.
• The FDA classified the action as a Class I recall, its most serious recall category.
• The BioZorb litigation reached a global settlement by January 2026.
• In a June 2026 update, the FDA reported 252 injuries associated with the recalled devices and no reported deaths.
• New claims are not currently being reviewed.

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What Is the BioZorb Marker?

BioZorb, along with the smaller BioZorb LP version, is a three-dimensional implantable marker made by Hologic. Surgeons placed it in the breast during or after a lumpectomy in patients treated for breast cancer.

It held a set of permanent titanium marker clips inside a bioabsorbable structure. The marker had two jobs:

• Doctors could see it on medical images after surgery. (Although some doctors used it to help plan radiation treatment, the FDA said BioZorb was not specifically cleared or approved for that purpose.)
• Its plastic framework was designed to be absorbed by the body over one year or longer, while the titanium clips remained permanently.

That the marker would absorb was central to how the device was marketed and sold.

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What Went Wrong?

The core failure was simple. In many patients, the device did not absorb the way it was supposed to.

Instead of dissolving, it stayed in place, hardened, shifted, or worked its way toward the surface. The complications patients reported included:

• Failure to resorb
• Migration away from the original site
• Erosion or protrusion through the skin
• Infection
• Seroma or fluid buildup
• Chronic pain
• Scarring or fibrosis

Some patients needed a second surgery to remove the device. For many of them, that meant another operation after they had already been through cancer treatment.

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Why Was BioZorb Recalled?

BioZorb was recalled because it had the potential to cause severe injuries. Hologic recalled the markers in 2024.

In December 2024, the FDA classified the BioZorb action as a Class I recall, which is the most serious category the agency uses. A Class I designation means the FDA concluded that use of the device could cause serious injury.

According to the FDA, the recall involved all unused BioZorb Marker and BioZorb LP Marker devices, and providers were told not to implant them.

The recall gave plaintiffs additional support for claims that were already moving through the courts.

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What Did the Lawsuits Allege?

Injured patients sued Hologic in federal court. The central claims were design defect and failure to warn. Plaintiffs argued the marker was defectively designed because it didn’t reliably absorb, and that Hologic failed to warn patients and surgeons about that risk.

Some complaints went further, alleging that the company promoted the device beyond its cleared use as a radiographic marker and marketed it as a way to fill the space left after a lumpectomy.

The cases were consolidated before Judge Allison Burroughs in the U.S. District Court for the District of Massachusetts.

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How Did the Litigation Progress?

The cases moved quickly.

• Hologic succeeded on some arguments but failed to eliminate several key claims before trial.
• The court allowed key failure-to-warn, design-defect, and negligence claims to continue.
• In one bellwether case, the court found a triable dispute over whether an inadequate warning contributed to the plaintiff’s injuries.
• The court dismissed or limited certain other claims, depending on the plaintiff and applicable state law.

Bellwether trials are early test cases that give an idea of how juries are likely to respond to the case. The first of these was scheduled for September 2025 and then pushed to January 2026.

In December 2025, just weeks before that trial, the judge paused all litigation deadlines. That pause was a strong signal that the parties were deep in settlement talks.

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What Happened With the 2026 Settlement?

The parties reached an agreement in principle in November 2025 and executed a formal settlement agreement on January 7, 2026. The agreement was intended to resolve the majority of the BioZorb cases.

The specific payout amounts and settlement terms were not made public. By that point, complaints had been filed on behalf of approximately 200 plaintiffs.

Earlier in the case, commentators had floated possible settlement-value ranges, but those were outside estimates, not the actual confidential terms of the deal.

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Can You Still File a BioZorb Lawsuit?

For practical purposes, no. The litigation has been settled globally, and as of late 2025, most attorneys were no longer reviewing new BioZorb claims. This was an inventory-style resolution covering cases that had already been filed, not an open class action with a public claims portal that new claimants can register through.

If you received a BioZorb marker and were never part of the litigation, there is no active intake process to join at this point.

However, the broader lesson holds for any device injury. Deadlines matter, and they are unforgiving. Statutes of limitations vary by state, and once the deadline passes, the right to sue is gone for good.

If you believe a medical device has harmed you, speak with an experienced product liability attorney promptly about your options and any deadlines that apply.

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Real Advocacy with the Defective Medical Device Attorneys at Bernheim Kelley

Bernheim Kelley handles defective medical device and product liability cases, and we work with referring attorneys on these cases across the U.S. If you have questions or believe you have a defective medical device claim, reach out to our team right away. We’ll take a look and Keep It Real with you about your options.