Cytal recallZ-1819-2026 · Integra LifeSciences Corp. (NeuroSciences) · initiated Mar 19, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Increased rate of out-of-specification endotoxin results.
FDA root cause category: Under Investigation by firm
What the company 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.
Recall details
- Recall number
- Z-1819-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 19, 2026
- Posted by the FDA
- Apr 15, 2026
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Quantity
- 7 units
- Product code
- KGN
- FDA submissions
- K152721
- 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 description
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Code information (models, lots, serial numbers)
Product ID: BMM0710. UDI-DI: 00386190001103. Lot Numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, 7593013.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cytal® BMM0710Acell, Inc. · DRESSING, WOUND, COLLAGEN1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98607).
- Z-1816-2026 · Open, ClassifiedCytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
- Z-1817-2026 · Open, ClassifiedCytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
- Z-1818-2026 · Open, ClassifiedCytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
- Z-1820-2026 · Open, ClassifiedCytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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