MediHoney Burn Gel Recall Lawsuit | 2026 Latest Updates

Integra LifeSciences recalled certain MediHoney Wound and Burn products and CVS Wound Gel in early 2026. Integra began notifying customers on January 16, 2026. The FDA also flagged the same packaging problem in a public alert on January 22, 2026. The recall affects five MediHoney items and two CVS Wound Gel lots. Packaging failures could break the sterile barrier around each product, raising the risk of infection. The FDA classified the action as a Class II Recall on March 6, 2026, and it remains open. Anyone with an affected product should stop using it right away, quarantine it, and contact Integra.

Latest MediHoney Burn Gel Recall Updates

March 6, 2026: FDA Classifies the Recall as Class II

The FDA updated its communication on March 6, 2026. It said the recall of MediHoney and CVS Wound Gel products has been classified as a Class II Recall [1]. The FDA’s classification database now lists the recall status as open. Integra LifeSciences had first told customers about the packaging problem two months earlier, in mid-January 2026. No new products or lots were added at the classification stage.

February 13, 2026: FDA Posts Formal Classification for Gel Tube Models

On February 13, 2026, the FDA’s classification database posted a formal recall record for the two MediHoney Gel tube models covered by this recall. The database assigned Recall Number Z-1363-2026 to these two products and listed 49,367 units in commerce, the only unit count published for this recall [2]. The Alginate Dressings and CVS Wound Gel lots still carry no matching record.

January 22, 2026: FDA Issues an Early Alert

The FDA sent an Early Alert to the public on January 22, 2026, six days after Integra’s own recall letter. The alert covered both the MediHoney products and CVS Wound Gel. The FDA called it a potentially high-risk device issue. Early alerts warn the public before a recall is fully classified, which happened six weeks later on March 6, 2026.

January 16, 2026: Integra Begins Notifying Customers

Integra LifeSciences began notifying customers on January 16, 2026, with an urgent letter calling it a voluntary medical device recall. The letter told customers to remove affected units from service and quarantine them. This was the first customer notice about the packaging problem behind this recall. The FDA warned the public about the issue six days later, on January 22.

Which MediHoney Burn Gel Products Are Affected?

The recall covers five MediHoney Wound and Burn products and two lots of CVS Wound Gel, listed below with their identifiers:

• MediHoney Calcium Alginate Dressing Rope, 3/4 x 12 inches (SKU 31012, UDI-DI 10381780486909, all lots)
• MediHoney Calcium Alginate Dressing, 2 x 2 inches (SKU 31022, UDI-DI 10381780486916, all lots)
• MediHoney Calcium Alginate Dressing, 4 x 5 inches (SKU 31045, UDI-DI 10381780486923, all lots)
• MediHoney Gel in Tube, 0.5 fl oz, Twistoff-Sterile (SKU 31805, UDI-DI 10381780486978, Recall Number Z-1363-2026)
• MediHoney Gel in Tube, 1.5 fl oz, Flipcap-Sterile (SKU 31815, UDI-DI 10381780486886, Recall Number Z-1363-2026)
• CVS Wound Gel, 1 oz tube, 24 cartons per case (catalog CVS405406, UPC 00050428452547, lots 2446 and 2428)

The SKU and UDI numbers appear on each product’s label. Only the two Gel tube models carry a formal FDA recall number. No such number has turned up yet for the other four products listed above.

Why Was MediHoney Burn Gel Recalled?

Integra LifeSciences recalled MediHoney Burn Gel because of packaging failures that could breach the product’s sterile barrier. Use of a product with a breached sterile barrier could lead to patient infection. The CVS Wound Gel lots had a different problem: Integra found production and process control issues on that manufacturing line. If the affected product is used, it may lead to infection, the FDA notice says. The recall affects the MediHoney Alginate Dressings and Gel tubes for the packaging issue, and specific CVS Wound Gel lots for the separate process problem. Reported incidents from both product lines are described in the next section.

Reported Incidents, Injuries, or Illnesses

As of December 19, 2025, Integra LifeSciences had reported 11 serious injuries linked to MediHoney Wound and Burn products. It had also reported three serious injuries linked to CVS Wound Gel products. No deaths were reported. These figures come from Integra’s own reports to the FDA, current only through the December cutoff date. A reported injury is not proof that a specific product caused it. Anyone hurt by a recalled MediHoney or CVS Wound Gel item should tell their doctor and report the injury to the FDA or to Integra directly. The next section explains what to do with a recalled product you still have.

What Should Consumers Do?

Anyone with an affected MediHoney or CVS Wound Gel product should take the following steps:

1. Stop using the product right away, and remove any affected units from service.
2. Quarantine any remaining units so no one else uses them by mistake.
3. Discard any expired stock according to your facility’s usual disposal policy for medical waste.
4. Forward the recall notice to anyone else who might use the product.
5. Contact Integra LifeSciences customer service at 1-800-654-2873 or custsvcnj@integralife.com, or report the issue through the FDA’s MedWatch program.
6. Watch for signs of infection, and call a health care provider right away if you notice any, per MedlinePlus guidance on wound care [3].
7. If the product was already used and standard wound care was followed, no additional follow-up is needed, per the FDA notice.

Other Recalls, Warnings, or International Actions

Three earlier MediHoney recalls came before this one. Each cited a packaging or sterile-barrier problem. Recall Z-1168-2025 covered a MediHoney Gel dressing, from January 10, 2025, with 12,166 units [4]. Recall Z-2505-2025 covered MediHoney Paste, from August 5, 2025, with 15,441 units [5]. Recall Z-2506-2025 covered MediHoney Tube products, from the same day, with 141,620 units [6]. On February 11, 2026, Health Canada published a separate Type II recall, RA-81591, for other MediHoney products made by Derma Sciences: Derma Cream, Leptospermum Honey Tube, and Barrier Cream, different products than this recall [7].

Legal Options

No lawsuit tied to this recall has been reported. A recall does not automatically create liability or a right to compensation. Someone who thinks a recalled MediHoney or CVS product caused an injury can talk to a lawyer. A product liability lawsuit can claim a maker let a known defect reach users.

Filing Deadlines

Deadlines for filing an injury claim come from state law, not from this recall. They depend on where the person lives. The clock can also depend on when the injury happened and when it was diagnosed. Some states start counting at diagnosis. A missed filing deadline can end a claim even when the underlying facts are strong. Anyone thinking about a MediHoney claim should speak with a lawyer soon.

Frequently Asked Questions

What Are the Symptoms of an Infection from a MediHoney Wound Dressing?

Symptoms of an infection from a MediHoney wound dressing include redness, increased pain, yellow or green pus, or excessive clear fluid around the wound, and a fever of 100°F (37.7°C) or higher for more than four hours. Call a health care provider right away if these occur.

Who Makes MediHoney Wound and Burn Products?

Integra LifeSciences makes MediHoney Wound and Burn products, including the items in this recall. Integra agreed to buy Derma Sciences in January 2017, and the next day Derma Sciences agreed to buy the MediHoney brand from its longtime owner, Comvita, bringing MediHoney under Integra.

What Products Were Included in the Three Earlier MediHoney Recalls?

The three earlier MediHoney recalls covered a Gel dressing (model 31815) in Z-1168-2025, a Paste product (model 31505) in Z-2505-2025, and Tube products (models 31515 and 31535) in Z-2506-2025, all for similar packaging problems.

Was Model 31815 Also Part of an Earlier MediHoney Recall?

Model 31815, the MediHoney Gel in Tube 1.5 fl oz included in this recall, was also part of an earlier recall: it carries the same model number and UDI listed in the Z-1168-2025 recall from January 2025, so this product was recalled twice, under two separate actions.

Where Were the Recalled MediHoney Products Distributed?

The recalled MediHoney products were distributed nationwide, according to the FDA’s classification database, which names Texas, Michigan, Florida, Indiana, Missouri, and California among the states that received them, alongside several others.

How Much Did Derma Sciences Pay to Acquire the MediHoney Brand?

Derma Sciences paid $13.3 million in cash for the MediHoney brand, buying it from Comvita in January 2017, a day after Integra LifeSciences agreed to acquire Derma Sciences itself, in a pair of deals struck the same week.

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=217786
3. https://medlineplus.gov/ency/patientinstructions/000741.htm
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=212018
5. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=215512
6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=215513
7. https://recalls-rappels.canada.ca/en/alert-recall/medihoneyr-wound-and-burn-products