MediHoney Paste (Integra) – packaging failure (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: MediHoney Product Name: MediHoney Paste Model/Catalog Number: 31505 Product Description: MediHoney Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.
Brand
Integra LifeSciences Corp. (NeuroSciences)
Lot Codes / Batch Numbers
Model/Catalog Number: 31505, UDI: 10381780486930, Lot #s: 2150, 2336, 2151, 2337, 2201, 2414, 2209, 2415, 2217, 2417, 2232, 2428, 2241, 2434, 2301, 2435, 2312, 2505, 2313, 2508, 2314, 2509, 2328
Products Sold
Model/Catalog Number: 31505; UDI: 10381780486930; Lot #s: 2150, 2336, 2151, 2337, 2201, 2414, 2209, 2415, 2217, 2417, 2232, 2428, 2241, 2434, 2301, 2435, 2312, 2505, 2313, 2508, 2314, 2509, 2328;
Integra LifeSciences Corp. (NeuroSciences) is recalling Brand Name: MediHoney Product Name: MediHoney Paste Model/Catalog Number: 31505 Product Description due to Packaging failures were identified which could lead to a breach in the sterile barrier.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaging failures were identified which could lead to a breach in the sterile barrier.
Recommended Action
Per FDA guidance
On August 5, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions for Customers: If you have units of the impacted product remove them immediately from service and quarantine them. 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. Complete the entirety of the Acknowledgement Form and send via email to FCA4@integralife.com or FAX to 1-609-750-4220. Keep a copy of the form for your records. Actions for Distributors: If you have products listed in Table 1, remove the product from further distribution. Complete the entirety of the Acknowledgement Form and send via email to FCA4@integralife.com or FAX to 1-609-750-4220. Keep a copy of the form for your records. Check your customer traceability records and notify them if they have any shipments of above catalog and lot numbers. Modify the acknowledgement form to create one from you to your customers. Collect completed response forms and affected product from your customers and indicate total quantities and lots in distributor reply form. For questions regarding these instructions, please contact Customer Service: Monday - Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873 email: custsvcnj@integralife.com Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Integra is dedicated to patient safety and manufacturing excellence. We continue to make numerous quality improvements and investments in our facilities around the world. In addition, we are improving our processes in accordance with applicable regulations. We sincerely apologize for any inconvenience this voluntary recall may cause and thank you for your cooperation in this effort.
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
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