The affected products and recommendations for what to do with the devices below have changed. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
The FDA is aware that BD and their subsidiary CareFusion have issued an updated letter notifying affected customers of worse performance, under certain use cases, for the BD Alaris Pump Module model 8100. Due to the difficulty in recognizing these performance issues, users may fail to identify them as the cause of clinically significant changes in a patient’s condition. The letter also provides updates regarding the removal and discontinuation of certain BD Alaris Pump Infusion Sets.
The performance data and information in this letter replaces information previously communicated in BD field action MMS-25-5311.
Affected devices:
- Product Description: BD Alaris Pump Infusion Sets compatible with BD Alaris Pump Module Model 8100
- Software: BD Alaris with Guardrails Suite MX, versions up to v.12.6
What to Do
Identify and discard discontinued Alaris Pump Sets. Use clinically appropriate alternate sets; if alternate sets are limited in quantity, prioritize use in critical-care, neonatal, infant, and pediatric care areas. Review the Pump Infusion Set Performance Disclosures and make any necessary adjustments to clinical use, set selection, or pump use. BD’s full customer letter is available on its website.
On August 19, 2026, BD and CareFusion sent affected customers a letter recommending the following actions:
- Immediately identify and discard any sets listed within “Attachment C: Discontinued Alaris Pump Sets” in BD’s customer letter per your facility’s procedures. These products are also listed in the Discontinued Sets tab of the Affected Product spreadsheet above.
- If a set is included on Attachment C as discontinued, identify an alternate BD Alaris Pump infusion set that is clinically appropriate and specific to the use case.
- If alternate sets are limited in quantity, they should be prioritized for use in critical-care, neonatal, infant, and pediatric care areas.
- Review the Pump Infusion Set Performance Disclosures in Attachment B of BD’s customer letter and make any necessary adjustments to clinical use, set selection, or pump use.
- If performance for the BD Alaris Pump with the identified infusion sets is not clinically appropriate, you should use an alternative pump, such as the BD Alaris Syringe Module or an alternative syringe pump if Alaris is not available.
- If no syringe pumps are available, the recalled pump infusion sets may be utilized with caution, enhanced clinical monitoring, and adherence to previously communicated warnings. See Attachment D of BD’s customer letter for Alaris System Label Warnings.
- Implement the Risk Mitigation steps outlined in the v12.3-v12.6 BD Alaris Infusion System User Manual and summarized below:
- Rate and Bolus Accuracy
- Avoid hanging the solution container below the BD Alaris Pump Module, or higher than 21 inches above the top of the BD Alaris Pump Module.
- Time to Alarm (TTA)
- When loading the set, ensure that tubing is directly over the pressure sensors.
- Ensure that all clamps are open; there are no kinks or collapses in the tubing outside of the pump; drops are flowing in the drip chamber. Ensure that the vent is open if applicable.
- Do not use Selectable pressure mode with a setting above 50 mmHg for rates less than 10 mL/h.
- Post Occlusion Bolus Volume (POBV)
- When addressing an occlusion (clearing) ensure that the fluid flow to the patient is OFF.
- Disconnect the tubing to relieve excess pressure through a stopcock if present. Weigh the risks of disconnection with the risks of an unintended bolus.
- Rate and Bolus Accuracy
Reason for Recall
BD stated that some Alaris Pump sets with restrictive components and designs (such as closed male luer, filters, check valves, Y-sites, microbore tubing, etc.) perform worse than previously disclosed. The deviations most commonly occur at low programmable rates under 1 mL/h and at or under 5 mL of “bolus volume”.
BD has continued to test BD Alaris Pump Infusion Sets to update infusion set performance data for accuracy. This testing found that the previously claimed performance was overestimated, and, in some instances, the infusion performance is significantly worse.
Performance attributes that differ from previously communicated values have the potential to result in greater degrees of under- or over-infusion, delayed time to occlusion alarms, and bolus dose inaccuracies. These examples of performance issues may not be readily detected by users.
The severity and nature of the outcomes resulting from this communicated performance depend on various factors but, for the most vulnerable, high-risk populations (i.e., neonates, pediatrics, critically ill patients), could result in serious adverse events or death, as these higher risk patients are more likely to receive lower rate and/or lower volume infusions, such as antiarrhythmics or blood-pressure supporting medications.
As of August 19, 2026, BD has not reported any serious injuries or deaths associated with this issue.
Device Use
The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces.
Additional FDA Resources
- FDA’s Enforcement Report
- Medical Device Recall Database
Additional Company Resources
Company-provided information is posted here by the FDA as a public service.
- BD U.S. Customer Letter [08/19/2026]
- BD Recall Webpage
- BD Provides Update on Voluntary Recall of Certain BD Alaris™ Pump Infusion Sets [9/12/2025]
- MMS-25-5311 BD Alaris™ [9/11/2025]
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact BD at:
| BD Contact | Contact Information | Areas of Support |
|---|---|---|
| Post Market Quality Operations | Email: BDRC49@bd.com | Customer Response Forms |
| BD Alaris Medical Affairs | Email: Alarismedicalaffairs@bd.com | Clinical Questions |
| BD Technical Support | Phone: 866-488-1408 Create a case at: https://bd.com/self-service |
Technical Service/Customer Service |
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database – Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Timeline of Communication Updates
| Date | Actions |
|---|---|
| 10/05/2026 | The FDA updated this communication to include additional affected products and provide current recommended actions and updated performance measures. |
| 09/29/2026 | The FDA updated this communication to include additional affected products, recommended actions, and performance measures. The update also notified the public that this issue was classified as a Class I Recall. |
| 07/17/2025 | The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. |
