FDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
American Nitrile Operations LLC is recalling 17,481,000 Opportunity Pro nitrile gloves nationwide 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential exposure to pathogens or chemicals.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Opportunity Pro blue nitrile patient examination gloves manufactured by American Nitrile Operations LLC. The recall covers 17,481,000 units distributed nationwide in the United States. Affected model numbers include 72-50800, 72-50801, 72-50802, 72-50803, and 72-50804, with specific lot numbers and UDI-DI codes listed in the agency's official record.
The recall was initiated because the gloves may exhibit manufacturing 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 lead to 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 for the model numbers and lot numbers identified in the recall notice. For more information, refer to the FDA recall record Z-3291-2026.
The recalled product
- Product
- Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800, 72-50801,72-50802,72-50803,72-50804 Product Description: Blue Nitrile patient examination glove
- Manufacturer
- American Nitrile Operations Llc
- Affected units
- 17,481,000
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 (3)
- AN250310947
- AN250310945
- AN250311327
Distribution
Distributed nationwide across the United States.
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