Recall Z-1816-2026— Integra LifeSciences Corp. (NeuroSciences)

Name: FDA recall Z-1816-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-19

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2026-03-19. It names one FDA 510(k) clearance: K152721. Product: Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.. Reason: Increased rate of out-of-specification endotoxin results..

Recalling firm: Integra LifeSciences Corp. (NeuroSciences)
Classification: Class II
Status: Ongoing
Initiated: 2026-03-19
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K152721 — Cytal Wound MatrixAcell, Inc.·cleared 2015-12-08

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

Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.

Reason for recall

Increased rate of out-of-specification endotoxin results.

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