CPR Shield With One Way Valve and Barrier Filter — Class II medical device recall Z-2117-2014
Terminated recall by Dynarex Corporation, reported 2014-08-06. "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong la
| Recall number | Z-2117-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dynarex Corporation, Orangeburg, NY, United States |
| Recall initiated | 2014-07-02 |
| Classified | 2014-07-25 |
| Reported by FDA | 2014-08-06 |
| Terminated | 2017-04-20 |
| Countries outside the US | CA, MX |
| Reason classes | labeling |
| Lot numbers | 28619, 28621 |
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.
Reason for recall
"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.
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-2117-2014. 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.