Home / Recalls / Integra LifeSciences Corp. (NeuroSciences) / Z-1363-2026

Z-1363-2026 Class II Ongoing

Recalled by Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ

FDA device recall Z-1363-2026 was initiated by Integra LifeSciences Corp. (NeuroSciences) on January 16, 2026 and is designated Class II. Reason for recall: Potential packaging failures, which could lead to a breach in the sterile barrier. The recall status is ongoing. Affected quantity: 49,367 units.

Recall Details

Product Type
Devices
Report Date
February 25, 2026
Initiation Date
January 16, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49,367 units

Product Description

MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.

Reason for Recall

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

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.).

Code Information

1. Model Number: 31805; UDI-DI: 10381780486978; Serial numbers: 2405, 2406, 2407, 2408, 2409, 2410, 2418, 2419, 2421, 2422, 2432, 2433, 2513, 2514, 2515. 2. Model Numbers: 31815; UDI-DI: 10381780486886; Lot Numbers: 2407, 2408, 2419, 2425, 2429, 2430, 2442, 2443, 2444, 2445, 2446, 2449, 2450, 2502, 2513, 2515, 2516.

Other recalls by Integra LifeSciences Corp. (NeuroSciences)

  • Z-2714-2026 Class II — OmniTract Surgical Retractor System, which includes 633 of the firm s product co (June 5, 2026)
  • Z-2173-2026 Class II — Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product (April 10, 2026)
  • Z-1820-2026 Class II — Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. (March 19, 2026)
  • Z-1818-2026 Class II — Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. (March 19, 2026)
  • Z-1816-2026 Class II — Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. (March 19, 2026)
  • Z-1817-2026 Class II — Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. (March 19, 2026)
  • Z-1819-2026 Class II — Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. (March 19, 2026)
  • Z-1828-2026 Class II — CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical asp (March 6, 2026)
  • Z-1364-2026 Class II — MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31 (January 16, 2026)
  • Z-1365-2026 Class II — Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound e (January 16, 2026)

FDA data resources