Halyard Health Recalls Sterling Nitrile Sterile Exam Gloves Due to Defects
Halyard Health is recalling Sterling Nitrile Sterile Powder Free Exam Gloves because they may be discolored and brittle, causing them to tear when put on.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect causes the gloves to tear, which is a functional failure rather than a direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.
Plain-English summary
Halyard Health is recalling 59 cases of Sterling Nitrile Sterile Powder Free Exam Gloves, size S, sterile. The affected products are identified by Product Code 53130 01 (105313001) and Lot numbers SM52741 and SM52721.
The recall was issued because the gloves may be discolored and brittle. This defect results in the inability of the user to put on the gloves without them tearing.
The affected gloves were distributed in California, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Minnesota, Montana, New Mexico, Oregon, Texas, and Utah. Users should stop using the affected gloves and contact Halyard Health for instructions on return or replacement.
The recalled product
- Product
- Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
- Manufacturer
- Halyard Health
- Category
- Medical Device — Exam Gloves
- Hazard
- Affected units
- 59
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 (2)
- Product Code: 53130 01 (105313001)
- Lot numbers: SM52741 and SM52721.
Distribution
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