dynarex Specimen Containers — Class II medical device recall Z-2057-2016
Terminated recall by Dynarex Corporation, reported 2016-07-06, distributed nationwide. Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exte
| Recall number | Z-2057-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dynarex Corporation, Orangeburg, NY, United States |
| Recall initiated | 2016-03-03 |
| Classified | 2016-06-27 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-06-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | labeling, sterility |
| Lot numbers | 31899, 32014, 32015, 32410, 32411 |
Product
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sample collection
Reason for recall
Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
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-2057-2016. 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.