Z-1168-2025Class II

Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815...

Name: Z-1168-2025 Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815...
Creator: Integra LifeSciences Corp.
Published: 2025-01-10
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2025-01-10 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney... on 2025-01-10. FDA classified it as Class II and gives the reason as "Potential that the induction seal is not completely sealed to the device tube packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1168-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-10
Posted: 2025-02-12
Recalling firm: Integra LifeSciences Corporation
Product: Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Description: MediHoney Gel with Active Leptospermum Honey is a moist dressing made of Active Leptospermum Honey in combination with gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing upon application. As a percentage of the overall dressing, MediHoney Gel dressing contains 80% medical grade honey by weight. 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. Component: No
Product code: FRO Dressing, Wound, Drug
Reason for recall: Potential that the induction seal is not completely sealed to the device tube packaging.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 10, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be Taken by Customers (Medical Facility): 1. If you do not have affected product, check the box, I do not have affected product. 2. If you do have units of the affected product (Table 1), remove them immediately from service and quarantine them. 3. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the total quantity of the affected product that you have. 4. 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. 5. Complete and return the Medical Facility Acknowledgement Form to [email protected] or FAX to 1-609- 750-4220. 6. Keep a copy of the form for your records. 7. When the form from you is received, and it is noted that you have affected product, Customer Service will contact you and provide an RMA number and directions to return the product. You can request a credit for the quantities returned. Actions to be Taken by Distributors: 1. If you do not have affected product, check the box, I do not have affected product. 2. If you do have the affected product (Table 1), remove the product from further distribution. 3. If you do have affected product, check the box I do have affected product. Record the total quantity of affected product you have. 4. Please check your customer traceability records for shipments of above catalog and lot numbers. 5. Forward this notice to any of your customers that have purchased the affected product (Table 1). 6. Complete and return the Distributor Acknowledgement Form to [email protected] or FAX to 1-609-750- 4220. 7. Keep a copy of the form for your records. 8. When the form from you and/or your customer is received, and it is noted that you and/or your customer has affected product, Customer Service will contact you and/or your customer and provide an RMA n
Quantity in commerce: 12,166 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, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY and the Virgin Islands and the country of Malaysia.
Product codes and lots: Model/Catalog Number: 31815; UDI #: 10381780486886; Lot #s: 2328, 2332 and 2333;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1168-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1168-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-12

Product code FRO

K101793UnclassifiedMedihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc. / cleared 2011-02-22

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)