FDA Recalls Defective Blue Nitrile Patient Examination Gloves

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Opportunity Flex blue nitrile patient examination gloves manufactured by American Nitrile Operations LLC. The recall affects approximately 36,793,000 units distributed nationwide in the United States. Specific model numbers and lot codes are listed in the agency's official recall notice.

The recall was initiated because the gloves may exhibit manufacturing defects, including tears, missing fingers, and debris. The FDA notes that using these 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 the defects could cause irritation or systemic toxicities.

Healthcare facilities and consumers who have purchased these gloves should stop using them immediately. Users should check their inventory for the specific model numbers and lot codes identified in the FDA recall notice. For more information, refer to the official FDA recall page or contact the recalling firm directly.

The recalled product

Product

Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number: 72-50900, 72-50901, 72-50902, 72-50903, 72-50904 Product Description: Blue Nitrile Patient examination gloves

Manufacturer

American Nitrile Operations Llc

Category

Medical Device — Examination Gloves

Hazard

• infection
• cross-contamination
• chemical-exposure

Affected units

36,793,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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