PlainRecalls

CME America, LLC

35 recalls on record · Latest: Dec 9, 2020

CME America, LLC Recall Insight

CME America, LLC appears on 35 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.042% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 9, 2020, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 35 entries, severity tagging shows 29 critical, 6 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 35 of 35 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (35). The date window on this page runs from Mar 18, 2020 to Dec 9, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 9, 2020

CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-contro…

FDA Devices Moderate Dec 9, 2020

CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-c…

FDA Devices Moderate Dec 9, 2020

CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-co…

FDA Devices Moderate Dec 9, 2020

CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delive…

FDA Devices Moderate Nov 4, 2020

CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number …

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-161XPS

FDA Devices Critical Jul 22, 2020

BodyGuard Microset With Female Luer, REF: A120-160XPSN

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-160X2YB

FDA Devices Critical Jul 22, 2020

BodyGuard BodySet, REF: A120-160SAS

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-160XSFK

FDA Devices Critical Jul 22, 2020

CMExpress Microbore Sets, REF: A120-161C

FDA Devices Critical Jul 22, 2020

BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV

FDA Devices Critical Jul 22, 2020

BodyGuard set with Female Luer, REF: A120-003XSN

FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Filter, REF: A120-160XSFE

FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-161XPSV

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-161XYBS

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A100-163XSL

FDA Devices Critical Jul 22, 2020

Standard BodySet with Needleless Connectors, REF: A120-125XS

FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF

FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Filter, REF: A100-164XESF

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A100-163XE90S

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-003XS2YV

FDA Devices Critical Jul 22, 2020

BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-112XSFK

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-160XYSF

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A100-163XESV

FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Filter, REF: A100-163XESF

FDA Devices Critical Jul 22, 2020

CMExpress Microbore Set, REF: A120-160C

FDA Devices Critical Jul 22, 2020

CMExpress Microbore Set, REF: A120-160CRV

FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY

FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-160XPS

FDA Devices Moderate May 13, 2020

BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for pa…

FDA Devices Critical Mar 25, 2020

CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress

FDA Devices Critical Mar 18, 2020

BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump Sy…

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds