PlainRecalls

CareFusion 303, Inc.

Compiled from official public sources by the editorial team.

165 recalls on record · Latest: Apr 1, 2026

CareFusion 303, Inc. Recall Insight

CareFusion 303, Inc. appears on 165 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.162% 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 Apr 1, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 15 entries, severity tagging shows 6 critical, 9 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 15 of 15 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 (15). The date window on this page runs from Aug 1, 2012 to May 21, 2014.

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 Critical May 21, 2014

Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump mo…

FDA Devices Moderate Apr 23, 2014

SmartSite Extension Set, Model No. 20029E, intravascular administration set.

FDA Devices Moderate Feb 12, 2014

SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors…

FDA Devices Moderate Feb 12, 2014

Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.

FDA Devices Critical Jan 1, 2014

Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is…

FDA Devices Moderate Dec 11, 2013

VersaSafe Extension Set, Model No. 21000M-007

FDA Devices Moderate Dec 11, 2013

SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Lue…

FDA Devices Moderate Oct 2, 2013

SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

FDA Devices Moderate Oct 2, 2013

SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a ne…

FDA Devices Moderate Oct 2, 2013

CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inser…

FDA Devices Critical Aug 14, 2013

Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main u…

FDA Devices Moderate Feb 27, 2013

CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the pat…

FDA Devices Critical Aug 29, 2012

Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utili…

FDA Devices Critical Aug 22, 2012

Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery o…

FDA Devices Critical Aug 1, 2012

Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare CareFusion 303, Inc. with Zimmer Biomet, Inc. →

Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.