FDA Recalls Performance Pro Nitrile Gloves Due to Defects
American Nitrile Operations is recalling Performance Pro blue nitrile gloves due to defects like tears and debris that may expose users to pathogens or chemicals.
What this means for you
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: The recall is classified as FDA Class II, and the source text describes a risk of harm (infection, cross-contamination, toxicity) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Performance Pro blue nitrile patient examination gloves manufactured by American Nitrile Operations Llc. The recall affects approximately 99,724,000 units distributed nationwide in the United States. Specific model numbers and lot codes are listed in the agency's official recall record Z-3289-2026.
The recall was initiated because the gloves may exhibit defects such as tears, missing fingers, and debris. The FDA notes that using defective gloves may lead to healthcare personnel and patients being exposed to infectious pathogens, which could result in infection or cross-contamination. Additionally, exposure to chemical agents through defective gloves may cause irritation or systemic toxicities.
Healthcare facilities and consumers who have purchased these specific lots of gloves should stop using them immediately. Users should check their inventory against the lot numbers provided in the official FDA recall notice. For more information or to report adverse events, contact the FDA or the recalling firm, American Nitrile Operations Llc.
The recalled product
- Product
- Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number: 72-RM50601,72-RM50602, 72-RM50603,72-RM50604 Product Description: Blue Nitrile Patient examination gloves
- Manufacturer
- American Nitrile Operations Llc
- Affected units
- 99,724,000
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)
- AN250511398
- AN250511322
Distribution
Distributed nationwide across the United States.
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