RecallRadar

FDA Device recall Z-1818-2026

Cytal Wound Matrix 2-Layer 10x15 cm

On 2026-04-22 the FDA classified a Class II recall of Cytal Wound Matrix 2-Layer 10x15 cm by Integra Lifesciences Neurosciences, citing increased rate of out-of-specification endotoxin results.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1818-2026
ClassificationClass II
Statusongoing
Initiated2026-03-19
Published2026-04-22
Last updated2026-09-13 11:58 UTC
CompanyIntegra Lifesciences Neurosciences
DistributionUS

Product

Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.

Reason

Increased rate of out-of-specification endotoxin results.

Identifiers

code_info
Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935…Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935, 7594266, 7593018, 7594288, 7594284, 7593013.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1818-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.