The FDA has posted 18 enforcement recalls of drug wound dressing devices since 2025, none of them Class I (most serious). Most recent report: Jul 15, 2026.
Surgical dressing manufactured out of specification (greater thickness).
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 product solution and the stainless steel sprin…
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 sterile products.
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 sterile products.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Dressing, Wound, Drug”). Informational only — verify against the FDA before acting.