Z-1364-2026Class II

MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045...

Name: Z-1364-2026 MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045...
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2026-01-16
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2026-01-16 / Open, Classified / root cause: packaging

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE... on 2026-01-16. FDA classified it as Class II and gives the reason as "Potential packaging failures, 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-1364-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-16
Posted: 2026-02-13
Recalling firm: Integra LifeSciences Corporation
Product: MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
Product code: FRO Dressing, Wound, Drug
Reason for recall: Potential packaging failures, which could lead to a breach in the sterile barrier.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Integra began notifying consignees on about 01/16/2026 via URGENT: VOLUNTARY MEDICAL DEVICE RECALL letter sent through FedEx and email. Consignees were instructed to immediately cease use of affected units and arrange for their return. Users were instructed to follow-up with their medical provider if the product has been used and they experienced any signs of wound infection. Consignees and distributors were instructed to forward the notification to those who utilize the product for awareness, and to customers, if further distributed. Additionally, consignees and distributors were requested to complete and return the provided Acknowledgement Form.
Quantity in commerce: 55,276 units
Distribution: Worldwide - US Nationwide distribution in the states of TX, MI, FL, IN, MO, CA, VA, NJ, PA, SC, TN, RI, NY and the countries of Australia, Austria, Bahrain, Canada, Finland, France, Germany, Greece, Guam, Guernsey, Hungary, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Korea (the Republic of), Kuwait, Lebanon, Madagascar, Malaysia, Netherlands (the), New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Tunisia, Uganda, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the), Virgin Islands (U.S.).
Product codes and lots: (1) Model Number: 31012; UDI-DI: 10381780486909; Lot numbers: A24008, A24057, B21123, B24075, C22159, C23177, C24148, D24190, E21365, E24254, E24255, G23393, H21523, H22452, H23443, I22512, I23464, J21693, L22706. (2) Model Number: 31022; UDI-DI: 10381780486916; Lot numbers: A23045, A23065, A25028, A25056, B23079, B25068, B25077, C21151, C21152, C21155, C21195, C22182, C22196, C23183, C23193, C25152, D23196, D23208, E21300, E22305, E22319, F21407, F21428, F21430, F22333, F24317, G23405, H21544, H22438, H23415, H23442, H23446, H24415, I21610, I21617, J22530 , J23551, J23560, J24622, K21723, K21739, K24625, K24646, L21838. (3) Model Number: 31045; UDI-DI: 10381780486923; Lot numbers: A21056, A22036, A22047, A24036, B21062, B21084, B21100, B21107, B21119, B25110, D21229, D21247, D22251, D22270, D22275, D23236, D23248, D24192, D24220, E21314, E21337, E21361, E22277, E23253, E23271, E24296, F21376, F22361, F22362, F22382, F23369, F23370, G21490, G21504, G22385, G23384, H21506, H21512, H21530, H23450, H23451, I22479, I22481, I22495, I23466, I23498, I24511, I24523, J21680, J21691, K21777, K21801, K21806, K22597, K22609, K22632, K22663, K24650, K24679, L21812, L21823, L22674, L22711, L23649.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1364-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1363-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-13
Z-1364-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-13
Z-1365-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-13

Product code FRO

K053095UnclassifiedHoney Alginate DressingDerma Sciences Canada, Inc. / cleared 2007-07-12

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)