Integra LifeSciences Corp. (NeuroSciences) recalls Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
Reason for recall
Increased rate of out-of-specification endotoxin results.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Cytal Wound Matrix 2-Layer 10x15 cm. Product ID:WSM1015UDI-DI 00386190001455.12 affected lots75796817582225758389375822277591942759194475839357594266
+4 more
7593018759428875942847593013
What the firm is doing
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.
DistributionShow detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1818-2026
- FDA 510(k) clearance · K152721The device's official FDA premarket clearance record
- FDA device classification · KGNOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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