FDA Devices recall · Reported February 25, 2015
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
Cme America, LLC recalled BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA… - a moderate-severity action.
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA… was recalled by Cme America, LLC in February 25, 2015. Reason: CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over deli…. Check the official notice for the remedy. Verify recall #Z-1126-2015 with the FDA Devices before acting.
The recall
Cme America, LLC issued this moderate-severity FDA Devices recall-CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over deli….
- Moderate
- severity level
- 3K units
- affected scope
- Class II
- classification
- February 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1126-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1126-2015) was formally reported on February 25, 2015, with the manufacturer initiating the action on January 16, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Cme America, LLC is listed as the recalling firm, operating out of Golden, CO. Federal records list the affected scope as 3,186.
The documented reason for this recall is: CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery. Distribution data in the federal record shows the product reached: Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1126-2015 |
| Date reported | February 25, 2015 |
| Date initiated | January 16, 2015 |
| Recalling firm | Cme America, LLC |
| Firm location | Golden, CO |
| Affected scope | 3,186 |
| Distribution | Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1126-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Why was this product recalled? ▼
Which agency issued this recall? ▼
Where was the recalled product distributed? ▼
Should I stop using a recalled medication or medical device? ▼
Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… → · All Medical Devices recalls
Methodology · Corrections · Archive as of August 2026