Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
CME America BodyGuard Infusion Pump System Recalled by CME America, LLC Due to Infusion Pump Systems may have a delivery inaccuracy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CME America, LLC directly.
Affected Products
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
Quantity: 30,596 pumps
Why Was This Recalled?
Infusion Pump Systems may have a delivery inaccuracy of up to 13%, which may result in 1) faster than expected drug delivery when infusing at a very low rate (0.1 mL/h), or 2) slower than expected drug delivery when infusing at high flow rates (greater-than 500 mL/h)
Where Was This Sold?
This product was distributed to 45 states: AL, AK, AZ, AR, CA, CO, CT, FL, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WI, WY, DC
About CME America, LLC
CME America, LLC has 47 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report