Recall Z-1363-2026— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1363-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-16

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2026-01-16. It names one FDA 510(k) clearance: K101793. Product: 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: Potential packaging failures, which could lead to a breach in the sterile barrier..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class II
Status: Ongoing
Initiated: 2026-01-16
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K101793 — MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEYDerma Sciences, Inc.·cleared 2011-02-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.