Recall Z-1364-2026— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1364-2026
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: K053095. 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. 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

K053095 — HONEY ALGINATE DRESSINGDerma Sciences Canada, Inc.·cleared 2007-07-12

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 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

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.