The Recall Desk

Manufacturer

CME America, LLC

48 recalls in our database name CME America, LLC as the manufacturing or recalling firm.

What the numbers show

Total
48
Critical
4
Severe
32
Most recent
2020-12-09

Of the 48 recalls from CME America, LLC we have scored against our rubric, 4 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 32 (67%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–48 of 48

  • SevereFDA (Devices)·Z-2560-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

    CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracy that could cause over-infusion or under-infusion of therapy.

    Product
    BodyGuard Microset, REF: A100-163XSFL
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2580-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling CMExpress Microbore Sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    CMExpress Microbore Sets, REF: A120-161C
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2568-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over-infusion or under-infusion of therapy.

    Product
    CMExpress Microbore Set, REF: A120-160CRV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2585-2020·2020-07-22

    CME America Recalls Infusion Sets Due to Delivery Inaccuracy

    CME America is recalling Standard BodySet infusion sets because they may deliver therapy at inaccurate rates, potentially causing over- or under-infusion.

    Product
    Standard BodySet with Needleless Connectors, REF: A120-125XS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2570-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver fluids with an inaccuracy exceeding plus/minus 13%, risking over- or under-infusion of therapy.

    Product
    BodyGuard Microset w/ Non-Vented Spike Connector, REF: A100-163XEBS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2583-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America is recalling 6,320 BodyGuard Microset infusion sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2578-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    CMExpress Microbore Sets, REF: A120-160CYFRV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2565-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard Microset, REF: A120-161XPSV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2572-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard Microset with Filter, REF: A100-164XESF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2586-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling 13,280 CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    CMExpress Microbore Set, REF: A120-160C
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2562-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

    CME America is recalling BodyGuard Microset infusion administration sets due to delivery inaccuracies that may cause over- or under-infusion of therapy.

    Product
    BodyGuard Microset, REF: A120-161XYB
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2581-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2574-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with an inaccuracy exceeding plus/minus 13%, potentially causing over- or under-infusion.

    Product
    BodyGuard Microset, REF: A100-163XSL
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2556-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with significant inaccuracy, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard Microset, REF: A100-163XES
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2554-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

    CME America, LLC is recalling BodyGuard Microset infusion administration sets because they may deliver therapy with an inaccuracy exceeding plus/minus 13%, potentially causing over- or under-infusion.

    Product
    BodyGuard Microset, REF: A120-160XPS
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-2582-2020·2020-07-22

    CME America BodyGuard Infusion Sets Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard infusion sets because they may deliver therapy at inaccurate rates, potentially causing over-infusion or under-infusion.

    Product
    BodyGuard set with Female Luer, REF: A120-003XSN
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1886-2020·2020-05-13

    CME America Recalls BodyGuard Microset Infusion Sets Due to Filter Defect

    CME America is recalling BodyGuard Microset infusion sets because the installed filter may have the incorrect pore size. The recall affects 30,300 units distributed nationwide.

    Product
    BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1474-2020·2020-03-25

    CME America BodyGuard Infusion Pump Systems Recalled for Delivery Inaccuracy

    CME America is recalling BodyGuard Infusion Pump Systems because they may deliver drugs at inaccurate rates, potentially causing faster or slower than expected medication administration.

    Product
    CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
    Category
    Medical Device
    Distribution
    45 states
  • CriticalFDA (Devices)·Z-1442-2020·2020-03-18

    CME BodyGuard Microset Infusion Sets Recalled for Fluid Under-Delivery

    CME America is recalling BodyGuard Microset infusion sets because they may under-deliver fluids when used with specific infusion pump systems.

    Product
    BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1126-2015·2015-02-25

    CME America Recalls BodyGuard 323 Infusion Pumps for Over-Delivery Risk

    CME America is recalling BodyGuard and BodyGuard 323 infusion pumps due to a potential for over-delivery of medication.

    Product
    BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
    Category
    Medical Device
    Distribution
    Distributed nationwide