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.

1–25 of 48

  • SevereFDA (Devices)·Z-0526-2021·2020-12-09

    CME America Recalls NeoThrive Syringe Pumps Due to Motor Wear

    CME America is recalling 4,182 NeoThrive syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.

    Product
    CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0527-2021·2020-12-09

    CME America T-Syringe Pump Recall for Motor Wear and Fluid Damage

    CME America is recalling T34L PCA syringe pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may damage hardware.

    Product
    CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2021·2020-12-09

    CME America T-Syringe Pump T34 Recalled for Motor Wear and Hardware Cracks

    CME America is recalling 4,182 T-Syringe Pump T34 units because motor wear may cause silent under-infusion and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2021·2020-12-09

    CME America Recalls Neofeed Syringe Pumps Due to Motor Wear and Cracks

    CME America is recalling 4,182 Neofeed syringe pumps because motor wear may cause under-infusion without alarms and cracks may allow cleaning fluids to damage hardware.

    Product
    CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2021·2020-12-09

    CME America T-Syringe Pump Recalled for Motor Wear and Fluid Damage

    CME America is recalling 4,182 T-Syringe Pumps because motor wear may cause under-infusion without alarms, and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2021·2020-12-09

    CME America T-Syringe Pump Recalled for Motor Wear and Hardware Damage

    CME America is recalling T-Syringe Pumps because motor wear may cause silent under-infusion and cleaning fluids may crack hardware.

    Product
    CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2021·2020-11-04

    CMEAmerica BodyGuard Wall Charger Recalled for Charging Defect

    CME America LLC is recalling 27 BodyGuard Wall Chargers because they may not properly charge the infusion pump battery.

    Product
    CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 1
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-2567-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Sets Due to Delivery Inaccuracy

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

    Product
    BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
    Category
    Medical Device
    Distribution
    49 states
  • CriticalFDA (Devices)·Z-2553-2020·2020-07-22

    CME BodyGuard BodySet Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard BodySet, REF: A120-160SAS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2573-2020·2020-07-22

    CME 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, REF: A100-163XE90S
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2558-2020·2020-07-22

    CME America Recalls BodyGuard Microset Infusion Administration Sets

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

    Product
    BodyGuard Microset, REF: A120-160XSFK
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2588-2020·2020-07-22

    CME 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- or under-infusion.

    Product
    BodyGuard Microset With Female Luer, REF: A120-160XPSN
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2563-2020·2020-07-22

    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: A120-161XYBS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2587-2020·2020-07-22

    CME America Recalls CMExpress Needleless Y Site Microbore Sets

    CME America is recalling 1,824 CMExpress Needleless Y Site Microbore Sets due to delivery inaccuracy that could cause over- or under-infusion of therapy.

    Product
    CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2557-2020·2020-07-22

    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- or under-infusion of therapy.

    Product
    BodyGuard Microset, REF: A120-161XPS
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2569-2020·2020-07-22

    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 Set, REF: A120-161CYF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2579-2020·2020-07-22

    CME America Recalls CMExpress Microbore Sets Due to Delivery Inaccuracy

    CME America is recalling 4,234 CMExpress Microbore Sets because they may deliver fluids with significant inaccuracy, potentially causing over- or under-infusion of therapy.

    Product
    CMExpress Microbore Sets, REF: A120-160C2YRV
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2564-2020·2020-07-22

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset with Filter, REF: A100-163XESF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2584-2020·2020-07-22

    CME America BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF
    Category
    Medical Device
    Distribution
    49 states
  • SevereFDA (Devices)·Z-2589-2020·2020-07-22

    CME BodyGuard Microset Infusion Sets Recalled for Delivery Inaccuracy

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

    Product
    BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV
    Category
    Medical Device
    Distribution
    49 states