An FDA-recorded root-cause determination. The FDA lists 29 recalls with this root cause since 2025. Most recent report: Jul 15, 2026.
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
Sterile anchors my lack sterility assurance.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Certain lots of product have the potential for a sterile barrier breach.
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.