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Open, Classified

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

FDA Recall Z-1364-2026 · Posted 2026-02-13

Recalling FirmIntegra LifeSciences Corp. (NeuroSciences)
Recall StatusOpen, Classified
Product CodeFRO
Date Initiated2026-01-16
Product Quantity55,276 units

Reason for Recall

Potential packaging failures, which could lead to a breach in the sterile barrier.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053095HONEY ALGINATE DRESSINGDerma Sciences Canada, Inc. · 2007-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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