Non-sterile — Class II medical device recall Z-2320-2024
Ongoing recall by SVS LLC, reported 2024-07-17, distributed nationwide. Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when us
| Recall number | Z-2320-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SVS LLC, Charlotte, NC, United States |
| Recall initiated | 2024-05-13 |
| Classified | 2024-07-09 |
| Reported by FDA | 2024-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 155,540 inner |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00811220035433, 00811220035440, 00811220035457, 00811220035464, 00811220035471 |
| Lot numbers | AEAM1103, AEAM1104, AEAM1105, AEAM1106, AEAM1112, AEAN0204, AEAN0205, AEAN0206, AEAN0307, AEAN0308, AEAN0309, AEAN0310, AEAN0311, AEAN0312, AEAN0316, AEAN0317, AEAN0318, AEAN0319, AEAN0320 |
Product
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.
Reason for recall
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 box indicating another size).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2320-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.