Source: FDA MedWatch
Integra LifeSciences recalls MediHoney and CVS Wound Gel products
Integra LifeSciences is removing certain MediHoney Wound and Burn dressings and select CVS Wound Gel lots from usage and distribution after the FDA flagged potential sterile barrier breaches. The FDA notes the device could cause temporary or reversible health effects, and in rare cases serious harm, if a breached barrier leads to infection. The scope and recommended actions have not changed since the recall was announced.
In a January 16 recall communication, Integra asked facilities and distributors to halt use of affected units, quarantine them, and ensure expired stock is discarded per internal policies. The firm also directed distributors to identify and stop selling affected lots, check customer traceability, and provide finalized disposition data back to Integra via Distributor response processes. The company stated it would not be able to directly assist end users and would route questions back to distributors.
Around MediHoney Wound and Burn products, Integra highlighted packaging failures that could breach the sterile barrier, with infection risk if breached devices were used. For CVS Wound Gel, production and process control issues could similarly lead to infection or prevent device use due to packaging failures. Clinicians are advised to follow standard care if the recalled products were already used, and no extra patient follow-up is required in that scenario.
What facilities should do now
- Immediately remove affected MediHoney and CVS Wound Gel products from service and quarantine them.
- Notify all staff who use or handle the products and ensure they identify any remaining lots in clinical areas.
- Discard expired stock per facility policies and do not use any recalled products.
- For distributors: halt distribution of the affected lots, review customer traceability, and provide a completed response with quantities and lot numbers back to Integra.
Regulatory observers will be watching whether the recall expands to additional lots or product lines, as packaging and process-control gaps can signal broader quality-control issues. The timing matters: the action leverages an established recall protocol to minimize patient exposure and protect supply chains while Integra engages distributors to manage forward distribution changes.