Integra LifeSciences Corp. MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
Model 31515 UDI-DI: 10381780486824, Model 31535 UDI-DI: 10381780486831, All lots distributed from 12/17/2020 to 07/22/2024 with expiration dates 08/01/2024 to 06/01/2028.
Products Sold
Model 31515 UDI-DI: 10381780486824; Model 31535 UDI-DI: 10381780486831; All lots distributed from 12/17/2020 to 07/22/2024 with expiration dates 08/01/2024 to 06/01/2028.
Integra LifeSciences Corp. is recalling MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube ( due to There is a potential for pinholes in the applicator pouch film which creates a sterility concern.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for pinholes in the applicator pouch film which creates a sterility concern.
Recommended Action
Per FDA guidance
An URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION letter dated 9/13/24 was sent to customers. Actions to be Taken by Customers (Medical Facility): 1. Complete the Medical Facility Acknowledgement Form below. 2. If you do have units of the impacted product (Table 1) remove the applicator immediately from service and discard it. 3. Forward this notice to those who utilize the product so they are aware of this recall and can identify any affected product that may remain in clinical areas. 4. Return the Medical Facility Acknowledgement Form to FCA2@integralife.com or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. OR Actions to be Taken by Distributors: 1. Complete the Distributor Acknowledgement Form below. 2. Please print and include a copy of this notice with every shipment of impacted products (Table 1) that have not yet been shipped to customers. 3. Return the Acknowledgement Form to FCA2@integralife.com or FAX to 1-609-750-4220. 4. Keep a copy of the form for your records. 5. Forward a copy of this notice to any customers that have purchased the impacted products (Table 1). Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that our customers have been notified and understand the nature of the field action. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
Important Notice
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