Z-2510-2025Class II

Brand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744...

Name: Z-2510-2025 Brand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744...
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2025-08-05
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-08-05 / Open, Classified / root cause: packaging

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of Brand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY HCS ADHESIVE SHEET... on 2025-08-05. FDA classified it as Class II and gives the reason as "Packaging failures were identified which could lead to a breach in the sterile barrier". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2510-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-05
Posted: 2025-09-03
Recalling firm: Integra LifeSciences Corporation
Product: Brand Name: MediHoney Product Name: MediHoney Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.
Product code: FRO Dressing, Wound, Drug
Reason for recall: Packaging failures were identified which could lead to a breach in the sterile barrier.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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 [email protected] 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 [email protected] 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: [email protected] 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.
Quantity in commerce: 1147 units
Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.
Product codes and lots: Model/Catalog Numbers: (1) 31722, (2) 31744; UDIs - (1) 10381780471387, (2) 10381780471394; Lot #s: (1) 44422, 14223, (2) 50423, 12523;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2510-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2505-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2506-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2507-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2508-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2509-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2510-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2511-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2512-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03

Product code FRO

K110546UnclassifiedMedihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyDerma Sciences, Inc. / cleared 2011-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)