CVS Burn Gel Recall Lawsuit | 2026 Latest Updates

Integra LifeSciences issued a voluntary recall of MediHoney Wound and Burn products on August 5, 2025. It recalled certain lots of CVS Wound Gel on January 16, 2026. The FDA posted an early alert on January 22, 2026.

A breach in the sterile barrier could lead to patient infection, the FDA said. The FDA classified the action as a Class II recall on March 6, 2026. The recall remains open.

Anyone with either recalled product should stop using it right away while they confirm whether it is covered, and watch for further updates from Integra LifeSciences and the FDA about this recall.

Latest MediHoney and CVS Wound Gel Recall Updates

March 6, 2026: FDA Classifies Recall as Class II

The FDA updated its early alert on March 6, 2026. It told the public it had classified the MediHoney and CVS Wound Gel issue as a Class II recall [1].

A Class II recall means the products may cause temporary or reversible health problems. Both device records still show the recall as open, and not all affected products have been corrected or removed.

January 22, 2026: FDA Issues Early Alert

On January 22, 2026, the FDA issued an early alert about the device issue. The alert warned the public about a possible sterile-barrier breach before the agency assigned a formal recall classification.

It named the same defect Integra LifeSciences had already reported to its customers. The notice listed the MediHoney SKUs and the CVS Wound Gel model and lot numbers covered by the issue.

January 16, 2026: Integra Recalls Certain CVS Wound Gel Lots

On January 16, 2026, Integra LifeSciences sent a letter to affected customers and began removing certain CVS Wound Gel lots. The recall, numbered Z-1365-2026, covered 2,906 units of Model CVS405406 [2].

Integra cited production and process-control issues with the private-label gel. The FDA’s device-recall record for this action still lists it as open and classified. It was posted February 13, 2026.

August 5, 2025: Integra Recalls MediHoney Wound and Burn Products

On August 5, 2025, Integra LifeSciences initiated a recall, numbered Z-2506-2025, of all MediHoney Wound and Burn products, covering 141,620 units distributed worldwide [3]. It sent customers a First Notification letter the same day [4].

Integra traced the recall to a defect in the packaging that put the sterile barrier at risk. It distributed the affected products to medical facilities and distributors, not through retail sale, according to its customer letter.

Which CVS Burn Gel Products Are Affected?

The recall covers these MediHoney and CVS Wound Gel products, each one identified on the recall notice by SKU, model, and lot number:

• MediHoney Wound and Burn products, calcium alginate dressings and gel-in-tube devices, SKUs 31012, 31022, 31045, 31805, and 31815, all lots
• CVS Wound Gel, a private-label CVS product, Model CVS405406, lots 2428, 2446, 2509, and 2514

Integra LifeSciences Corp. (NeuroSciences), based in Princeton, New Jersey, makes and recalled both product lines, distributing them to medical facilities and distributors worldwide.

It has not stated where individual consumers could buy either recalled product at retail, according to the FDA’s device-recall records.

Why Was the CVS Burn Gel Recalled?

Integra LifeSciences recalled the MediHoney Wound and Burn products because it found a packaging defect that risked opening the product’s sterile barrier and raising the infection risk at the wound site.

It recalled certain CVS Wound Gel lots because of separate production and process-control issues that could also breach the barrier and raise the same infection risk.

The FDA’s early-alert notice lists these two reasons separately, one for the MediHoney device-recall record and one for the CVS Wound Gel device-recall record.

The two product lines have different underlying causes, even though the FDA covered both problems in the same early-alert notice and in each product’s device-recall record.

Reported Incidents, Injuries, or Illnesses

Integra LifeSciences has reported 11 serious injuries linked to MediHoney Wound and Burn products and three linked to CVS Wound Gel, as of December 19, 2025, with no deaths reported for either product line.

The MediHoney injuries followed the packaging failures that could breach the sterile barrier, and the CVS Wound Gel injuries followed the separate production and process-control issues, out of 141,620 MediHoney units and 2,906 CVS Wound Gel units recalled worldwide.

A report of an injury does not by itself prove that a specific product caused it. The FDA’s device-recall records for MediHoney, Z-2506-2025, and CVS Wound Gel, Z-1365-2026, include these figures as of the same reporting cutoff.

What Should Consumers Do?

If you have a MediHoney or CVS Wound Gel product covered by this recall, take these steps:

1. Stop using the affected MediHoney or CVS Wound Gel product right away.
2. Remove it from service and quarantine it separately from other medical supplies right away.
3. Forward the recall notice to anyone else who uses the product at your facility.
4. If you distribute the product, check your traceability records and complete Integra’s acknowledgement form before returning or discarding stock.
5. Contact Integra customer service at 1-800-654-2873 or custsvcnj@integralife.com, Monday through Friday, 8:00 a.m. to 8:00 p.m. Eastern time. You may also report a problem to the FDA’s MedWatch program.
6. Watch for signs of wound infection, which MedlinePlus lists as redness, increased pain, or pus [5]. Seek medical care right away if a fever of 100°F or higher lasts more than four hours.

Legal Options

The reported injuries described above, tied to a sterility and production-control defect, may give some people a reason to have a legal review.

No lawsuit, class action, or multidistrict litigation has been confirmed against this recall. The Judicial Panel on Multidistrict Litigation‘s March 2, 2026 docket list carries no MediHoney, CVS Wound Gel, or Integra LifeSciences entry [6].

A recall does not automatically establish liability or eligibility for compensation. You can find more information about product liability claims involving recalled medical devices.

Frequently Asked Questions

What Are the Symptoms of an Infection from MediHoney or CVS Wound Gel?

An infection from MediHoney or CVS Wound Gel can follow a sterile-barrier breach. Watch for black edges around the wound, a sign of dead tissue, bleeding that will not stop after ten minutes, and pain that will not ease even with medicine.

Who Makes MediHoney and CVS Wound Gel?

Integra LifeSciences Corp. makes both MediHoney Wound and Burn products and CVS Wound Gel. The company, based in Princeton, New Jersey, recalled both product lines. Derma Sciences Inc. is named as the legal manufacturer of record on the recall notice published in Germany for EU vigilance.

Why Does the CVS Wound Gel Recall Affect Only Certain Lots?

The CVS Wound Gel recall affects only certain lots because the FDA’s device-recall record limits the production and process-control issue to lots 2428, 2446, 2509, and 2514 of Model CVS405406. That record carries Recall Event ID 98175, a separate event number from the MediHoney recall’s Event ID 97404.

Can Facilities Still Have MediHoney or CVS Wound Gel in Storage?

Yes, a facility can still have MediHoney or CVS Wound Gel in storage since the recall stays open. The FDA’s device-recall record for MediHoney was posted September 3, 2025, and the action has not been terminated. The notice asks facilities to quarantine stock, not destroy it right away.

Is the CVS Honey Pad Also Part of This Recall?

No, the CVS Honey Pad is not part of this recall. It is a separate FDA device-recall record, Z-2512-2025, initiated the same day as the MediHoney recall, August 5, 2025. It shares Event ID 97404 with MediHoney but is not on the FDA’s public early-alert page.

Was This Recall Also Announced Outside the United States?

Yes, this recall was announced outside the United States too. Germany’s BfArM published a field-safety notice describing the same MediHoney recall already announced in the United States. It republishes Integra’s own notice for European vigilance and describes the same packaging failure. It is not a separate foreign investigation.

References

1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/wound-and-burn-dressing-recall-integra-lifesciences-removes-certain-medihoney-and-cvs-wound-and-burn
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=217788
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=215513
4. https://www.products.integralife.com/file/products/us_medihoney_customer_letter_first_notification.pdf
5. https://medlineplus.gov/ency/patientinstructions/000741.htm
6. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-March-2-2026.pdf