BodyGuard 323 pump — Class II medical device recall Z-1126-2015
Terminated recall by CME America, LLC, reported 2015-02-25, distributed nationwide. CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over deliv
| Recall number | Z-1126-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CME America, LLC, Golden, CO, United States |
| Recall initiated | 2015-01-16 |
| Classified | 2015-02-19 |
| Reported by FDA | 2015-02-25 |
| Terminated | 2017-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 3,186 |
| Model numbers | 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA, 100-603XSAP |
Product
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Reason for recall
CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
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-1126-2015. 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.