O&M HALYARD INC: Medical Device Recall in 2021 - (Recall #: Z-0317-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

Product Classification:

Class II

Date Initiated: September 27, 2021

Date Posted: December 8, 2021

Recall Number: Z-0317-2022

Event ID: 88846

Reason for Recall:

All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.

Status: Ongoing

Product Quantity: 2,928 cases (5,856,000 gloves)

Code Information:

All lots of the following sizes: a. XS, REF 47459, UDI (01)20680651474593 b. S, REF 47460, UDI (01)20680651474609 c. M, REF 47461, UDI (01)20680651474616 d. L, REF 47462, UDI (01)20680651474623 e. XL, REF 47463, UDI (01)20680651474630

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of EU/Canada.

Voluntary or Mandated:

Voluntary: Firm initiated