Recall database

Mask, Surgical recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0729-2025

O&M HALYARD, INC. recalls O&M Halyard SOFT TOUCH II Surgical Mask

Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard.…

Surgical Mask
Nonconforming Material/Component

O&M HALYARD, INC.VAJan 1, 2025

Class IIOngoingZ-0728-2025

O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops

Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard.…

Surgical Mask
Nonconforming Material/Component

O&M HALYARD, INC.VAJan 1, 2025