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 50 entries, severity tagging shows 18 critical, 32 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 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 (50). The date window on this page runs from Jul 16, 2014 to Sep 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 Sep 9, 2020

BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional i…

FDA Devices Moderate Aug 26, 2020

Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion …

FDA Devices Moderate Aug 26, 2020

Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion par…

FDA Devices Moderate Aug 26, 2020

Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming …

FDA Devices Moderate Aug 26, 2020

Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion pa…

FDA Devices Moderate Aug 26, 2020

Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion para…

FDA Devices Critical Aug 12, 2020

Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris System PC Unit Model 8015. modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris Pump Module Model 8100, a modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris Pump Module Model 8100

FDA Devices Critical Aug 12, 2020

Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris PCA Module Model 8120, a modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris System PC Unit Model 8000 modular infusion pump and monitoring system

FDA Devices Critical Aug 12, 2020

Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system

FDA Devices Critical Mar 11, 2020

CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)

FDA Devices Critical Mar 11, 2020

CareFusion Alaris PCA Module, Model 8120

FDA Devices Critical Mar 11, 2020

CareFusion Alaris Pump Module, Model 8100

FDA Devices Critical Mar 11, 2020

CareFusion Alaris Syringe Module, Model 8110

FDA Devices Moderate Sep 11, 2019

Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933

FDA Devices Critical Jul 24, 2019

Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this reca…

FDA Devices Moderate Nov 14, 2018

Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFu…

FDA Devices Moderate Jun 13, 2018

Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient throu…

FDA Devices Moderate Jan 17, 2018

Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump mod…

FDA Devices Moderate Jan 17, 2018

Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump…

FDA Devices Moderate Oct 25, 2017

Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) …

FDA Devices Moderate Aug 23, 2017

VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to a…

FDA Devices Moderate Jul 19, 2017

Alaris Pump Module model 8100

FDA Devices Moderate Jul 12, 2017

Alaris PC Unit, Model 8015

FDA Devices Moderate May 3, 2017

SmartSite Add-On Bag Access Device, Model No. 10013365

FDA Devices Moderate Mar 29, 2017

Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.

FDA Devices Moderate Mar 22, 2017

MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305

FDA Devices Moderate Mar 22, 2017

MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a p…

FDA Devices Critical Jan 25, 2017

Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump of…

FDA Devices Moderate Oct 5, 2016

Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers…

FDA Devices Moderate Jul 6, 2016

Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris Sys…

FDA Devices Moderate May 11, 2016

Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

FDA Devices Moderate Mar 30, 2016

Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092

FDA Devices Moderate Mar 23, 2016

Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

FDA Devices Moderate Feb 24, 2016

Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anes…

FDA Devices Moderate Dec 30, 2015

Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the p…

FDA Devices Moderate Dec 30, 2015

Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2…

FDA Devices Moderate Nov 11, 2015

SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery o…

FDA Devices Critical Aug 26, 2015

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower …

FDA Devices Moderate Jun 24, 2015

Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power…

FDA Devices Moderate Apr 1, 2015

Alaris PC units, Model No. 8015. Infusion pump.

FDA Devices Moderate Feb 11, 2015

SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or …

FDA Devices Moderate Jul 16, 2014

SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458

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.