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PermeaDerm®
Stedical Scientific, Inc. · Model PDG XL · UDI-DI 00810125742255
FRO
Prescription
1
510(k) clearances
3,166
Adverse events (64 deaths)
82
Recalls
385
Facilities
Description
PermeaDerm® is an FDA-cleared biosynthetic wound matrix for the treatment of partial-thickness wounds, surgical wounds, trauma wounds, donor sites, and the coverage of meshed autografts.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-08 | ConvaTec, Inc | Surgical dressing manufactured out of specification (greater thickness). |
| 2026-04-27 | Oculus Technologies of Mexico, S.A. de C.V. | The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the produc |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-16 | Integra LifeSciences Corp. (NeuroSciences) | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| 2026-01-05 | Medline Industries, LP | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for |
| 2026-01-05 | Medline Industries, LP | Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| 2025-08-05 | Integra LifeSciences Corp. (NeuroSciences) | Packaging failures were identified which could lead to a breach in the sterile barrier. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.