Recalls / —

—#219201

Product

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

FDA product code

KGN — Wound Dressing With Animal-Derived Material(S)

Device class

Class U

Medical specialty

Unknown

510(k) numbers

K152721

Affected lot / code info

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

Why it was recalled

Increased rate of out-of-specification endotoxin results.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Integra LifeSciences Corp. (NeuroSciences)

Address

1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2026-03-19

Posted by FDA

2026-04-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #219201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.