HALYARD STERLING ZERO Nitrile Exam Gloves Recall for Discoloration and Loss of Elasticity
O&M Halyard is recalling HALYARD STERLING ZERO nitrile exam gloves in all sizes due to discoloration and loss of elasticity with aging, making the gloves difficult or impossible to don without tearing. Approximately 5.86 million gloves distributed worldwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II recall without reported illnesses or injuries. However, the functional defect in these exam gloves—discoloration and loss of elasticity preventing proper donning—represents a risk-of-harm in a safety-critical healthcare product where injury has not been reported, per the rubric's Score 3 criterion.
Plain-English summary
O&M Halyard Inc. is recalling HALYARD STERLING ZERO nitrile powder-free exam gloves in all sizes (XS, S, M, L, and XL). The recall affects approximately 2,928 cases (5,856,000 gloves) distributed worldwide, including the United States, European Union, and Canada.
The gloves may discolor and lose elasticity as they age. This degradation can result in the inability to don (put on) the gloves without tearing, potentially compromising their protective function in healthcare settings.
Healthcare facilities, providers, and consumers who have purchased these gloves should not use them and should contact their distributor or O&M Halyard Inc. for return or replacement options. Affected lot numbers include all lots of sizes XS (REF 47459), S (REF 47460), M (REF 47461), L (REF 47462), and XL (REF 47463).
The recalled product
- Product
- HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
- Manufacturer
- O&M HALYARD INC
- Category
- Medical Device — Exam Gloves
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distributed nationwide across the United States.
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