Cytal Wound Matrix 10x15 cm recalled over out-of-specification endotoxin results
Cytal Wound Matrix 2-Layer 10x15 cm dressings are being recalled because of an increased rate of out-of-specification endotoxin results. 452 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for out-of-specification endotoxin results in a wound-contact product, a risk of harm with no injuries reported in the source.
Plain-English summary
The Cytal Wound Matrix 2-Layer 10x15 cm, product ID WSM1015, UDI-DI 00386190001455, is being recalled. The action covers 452 units across the lots listed in the recall notice, including 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935 and 7594266.
The recall is due to an increased rate of out-of-specification endotoxin results. Endotoxin limits apply to products placed in contact with wounds because endotoxin can provoke a febrile or inflammatory response. The FDA classified the action as Class II.
Distribution was nationwide in the United States across a large number of states. The dressings are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the product ID, UDI-DI and lot numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Wound dressing
- Hazard
- endotoxin
- out-of-specification
- wound-care
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681
- 7582225
- 7583893
- 7582227
- 7591942
- 7591944
- 7583935
- 7594266
- 7593018
- 7594288
- 7594284
- 7593013.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22