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

Recall Insight

This FDA Devices action (record #Z-0317-2022) was formally reported on December 8, 2021, with the manufacturer initiating the action on September 27, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. O&M HALYARD INC is listed as the recalling firm, operating out of Alpharetta, GA. Federal records indicate 2,928 cases (5,856,000 gloves) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of EU/Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.