Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.

FDA device recall Z-1819-2026 · posted 2026-04-15 · Open, Classified

Recall details

Recalling firm

Integra LifeSciences Corp. (NeuroSciences)

Reason for recall

Increased rate of out-of-specification endotoxin results.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KGN

Quantity affected

7 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.

Date initiated

2026-03-19

Date posted

2026-04-15

Location

Princeton, NJ

Related 510(k) clearances