O&M HALYARD, INC.: Device Recall

Recall Details

Recall Number

Z-0983-2025

Classification

Class II

Product Type

Device

Recalling Firm

O&M HALYARD, INC.

Status

Ongoing

Date Initiated

11/26/2024

Location

Mechanicsville, VA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1440 units

Reason for Recall

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Product Description

Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A

Distribution Pattern

US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS, LA, MI, MN, MO, NC, NE, NY, TN, TX, VA, WI.

Other Recalls by O&M HALYARD, INC.

• Class II: Risk 07/17/2025
  Surgical drape packs may have open seals, which may compromise the sterility of the product.
• Class II: Risk 11/08/2024
  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 standard is printed on the packaging, compliance is required.
• Class II: Risk 11/08/2024
  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 standard is printed on the packaging, compliance is required.

View all recalls by O&M HALYARD, INC. →