FDA Devices recall · Reported February 4, 2015
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Baxter Healthcare Corp. recalled HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. P… - a moderate-severity action.
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. P… was recalled by Baxter Healthcare Corp. in February 4, 2015. Reason: The keypad buttons on HomeChoice devices may be activated without the operator pressing them.. Check the official notice for the remedy. Verify recall #Z-1031-2015 with the FDA Devices before acting.
The recall
Baxter Healthcare Corp. issued this moderate-severity FDA Devices recall-The keypad buttons on HomeChoice devices may be activated without the operator pressing them..
- Moderate
- severity level
- 200 units
- affected scope
- Class II
- classification
- February 4, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1031-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1031-2015) was formally reported on February 4, 2015, with the manufacturer initiating the action on October 21, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Baxter Healthcare Corp. is listed as the recalling firm, operating out of Deerfield, IL. Federal records list the affected scope as 200.
The documented reason for this recall is: The keypad buttons on HomeChoice devices may be activated without the operator pressing them. Distribution data in the federal record shows the product reached: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia. 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
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Reason for recall
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1031-2015 |
| Date reported | February 4, 2015 |
| Date initiated | October 21, 2014 |
| Recalling firm | Baxter Healthcare Corp. |
| Firm location | Deerfield, IL |
| Affected scope | 200 |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia |
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-1031-2015) 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.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
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Methodology · Corrections · Archive as of August 2026