Baxter Healthcare Corp. HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Brand
Baxter Healthcare Corp.
Lot Codes / Batch Numbers
all codes distributed between 4/15/2014 and 6/11/2014
Products Sold
all codes distributed between 4/15/2014 and 6/11/2014
Baxter Healthcare Corp. is recalling HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product code due to The keypad buttons on HomeChoice devices may be activated without the operator pressing them.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, LA, MD, MA, MI, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, UT, VT, VA, WA, WI, DC
Page updated: Jan 10, 2026