Class II — Dynarex Corporation
| Recalling firm | DYNAREX CORP. |
|---|---|
| Registered facility | DYNAREX CORP. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers. |
| Product | CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation. |
| Quantity | Domestic: 208 cases; Foreign: 42 cases |
| Distribution | Worldwide Distribution -- USA, Canada, and Mexico. |
| Initiated | 2014-07-02 |
| Classified | 2014-07-25 |
| Terminated | 2017-04-20 |
| Recall number | Z-2117-2014 |
| 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-2117-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68681/
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