CareFusion 303, Inc.
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.
BD Alaris System. The EtCO2 module is a capnograph indicated for continuous, noninvasive monitoring of end tidal carbon dioxide (EtCO2), fractional i…
Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion …
Alaris Pump Module Model 8100 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion par…
Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming …
Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion pa…
Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion para…
Alaris System PC Unit Model 8015, a modular infusion pump and monitoring system
Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Alaris Pump Module Model 8100
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
CareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)
CareFusion Alaris PCA Module, Model 8120
CareFusion Alaris Pump Module, Model 8100
CareFusion Alaris Syringe Module, Model 8110
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this reca…
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFu…
Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient throu…
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…
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…
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) …
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…
Alaris Pump Module model 8100
Alaris PC Unit, Model 8015
SmartSite Add-On Bag Access Device, Model No. 10013365
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a p…
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…
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…
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…
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anes…
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the p…
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2…
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery o…
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower …
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power…
Alaris PC units, Model No. 8015. Infusion pump.
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or …
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.
Data Sources
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.