Z-1818-2026Class II

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

Name: Z-1818-2026 Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015
Creator: Integra LifeSciences Corp. (NeuroSciences)
Published: 2026-03-19
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2026-03-19 / Open, Classified / root cause: sterility

FDA source

Integra LifeSciences Corp. (NeuroSciences) began a recall of Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015 on 2026-03-19. FDA classified it as Class II and gives the reason as "Increased rate of out-of-specification endotoxin results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1818-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-19
Posted: 2026-04-15
Recalling firm: Integra LifeSciences Corporation
Product: Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Product code: KGN Wound Dressing With Animal-Derived Material(S)
Reason for recall: Increased rate of out-of-specification endotoxin results.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Integra LifeSciences notified consignees on about 03/19/2026 via letter. Consignees were instructed to identify any affected units on hand and remove them immediately from service and quarantine them, complete and return the Acknowledgment Form and arrange for the return of affected units. Consignees were also instructed to forward to all affected personnel who utilize the product so they are aware of the recall and can identify any affected product that may remain in clinical areas. Distributors were instructed to identify any affected units on hand and remove them immediately from service and quarantine them, complete and return the Acknowledgment Form and arrange for the return of affected units. Distributors were also instructed to check customer traceability records and notify them if they have any shipments with affected units. They requested to modify the acknowledgement form to provide to customers, collect completed response forms and provide those numbers in the distributor reply form. Integra LifeSciences sent a second notification letter on about 03/20/2026, which updated the lot numbers affected. Consignees were asked to disregard the previous letter and replace it with the updated one. Directions for consignees and distributors did not change.
Quantity in commerce: 452 units
Distribution: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.
Product codes and lots: Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935, 7594266, 7593018, 7594288, 7594284, 7593013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1818-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1816-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1817-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1818-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1819-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15
Z-1820-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-04-22	2026-04-15

Product code KGN

K152721UnclassifiedCytal Wound MatrixAcell, Inc. / cleared 2015-12-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)