Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.

Recall Insight

This FDA Devices action (record #Z-2320-2024) was formally reported on July 17, 2024, with the manufacturer initiating the action on May 13, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. SVS LLC is listed as the recalling firm, operating out of Charlotte, NC. Federal records indicate 155,540 inner boxes units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner b… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.