An FDA-recorded root-cause determination. The FDA lists 17 recalls with this root cause since 2025, 1 of them Class I (most serious). Most recent report: Jul 22, 2026.
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testi…
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.