Class II — Dynarex Corporation
| Recalling firm | DYNAREX CORP. |
|---|---|
| Registered facility | DYNAREX CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton. |
| Product | dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection |
| Quantity | 399 cases/25 sleeves/20 cups & lids per sleeve |
| Distribution | US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International: Canada |
| Initiated | 2016-03-03 |
| Classified | 2016-06-27 |
| Terminated | 2018-06-06 |
| Recall number | Z-2057-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Dynarex Corporation (Z-2057-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73584/
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