O&M HALYARD Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model recall — FDA Z-2520-2025
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Overview of recall records associated with O&M HALYARD, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 4, Class III: 1.
Surgical drape packs may have open seals, which may compromise the sterility of the product.
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
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. However, if the…
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. However, if the…
Product was mislabeled as a Surgical Cap at its dispenser level.
This page summarizes recall records in which the official source identifies O&M HALYARD, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.