Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator — Class II medical device recall Z-1849-2014
Terminated recall by Western / Scott Fetzer Company, reported 2014-07-02, distributed nationwide. Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
| Recall number | Z-1849-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Western / Scott Fetzer Company, Westlake, OH, United States |
| Recall initiated | 2014-04-07 |
| Classified | 2014-06-23 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2016-10-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, CR, ES, FR, HN, IE, IN, IT, JP, KR, MX, MY, PA, TW |
| Quantity | 118,325 units |
| Model numbers | AGI-4430, ALQ-1877, ALQ-1878, ALQ-1967, ALQ-2033, ALQ-2041, INW-5153, PRX-9310, PRX-9415, PRX-9416, PRX-9416L, PRX-9427, PRX-9427L, RG3000, RG3001, RG3003, RG4000, RG4004, RG4004B, RMI-9672, VIT-11660, XRA-3100, XRA-3110, XRA-3110F, XRA-3120 and 20 more |
Product
Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
Reason for recall
Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
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-1849-2014. 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.