Packaging failed to protect the product — sterility breaches and shipping damage live here. The FDA lists 68 recalls with this root cause since 2025, 5 of them Class I (most serious). Most recent report: Jul 8, 2026.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Potential sterile breach of the pouches in which devices are packaged.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.