Class I recallOngoing

BD Alaris Infusion System recall — FDA event 97067

FDA · FDA event 97067 · Posted Aug 6, 2025

Published Aug 6, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On December 12, 2025, CareFusion 303, Inc. (BD) issued a updated "Urgent Medical device Recall Notice via E-Mail and physical mail. The updated notice includes important information on infusion sets as well as labeling updates. Previous notifications were sent on July 8,2025, July 17, 2025, September 11, 2025 and September 12, 2025. CareFusion ask consignees to take the following actions:
1. Review your inventory for the catalog numbers included in the updated letter. Remove and discard any remaining inventory per your facility guidelines.
2.To receive credit or replacement product, please return the completed customer response form attached to this notice.
3.Please contact your BD Clinical Consultants and Account Executives for alternative sets information.
4. Review the updated sets performance data included in the letter.
5. Circulate this notice within your facility network to ensure that all concerned personnel are made aware of this issue.
6. Distributors should provide a copy of this notice to all customers who may have purchased an Alaris Pump Module.
If you require further assistance, please contact: BD Technical Support at Phone: 888-812-3229; Phone hours: 6:00am to 5:00pm PT Monday Friday and Email: DL-US-INF-TechSupport@bd.com.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references BD Alaris Infusion System by Becton, Dickinson and Company.

Products affected by FDA event 97067
Model	Description	Lot / serial range	Manufactured	Status
Z-2180-2025	Z-2180-2025	REF: 10013186/ UDI: 07613203021173; REF: 2452-0007/ UDI: 10885403219870; REF: 2204-0007/ UDI: 10885403199363; REF: 24001-0007/ UDI: 10885403238666; REF: 10015012/ UDI: 10885403233951; REF: 2432-0007/ UDI: 10885403232329; REF: 2434-0007/ UDI: 07613203019682; REF: 2202-0007/ UDI: 10885403274039; REF: 11426965/ UDI: 10885403232558; REF: 10561554/ UDI: 10885403232565; REF: 10863358/ UDI: 10885403232466; REF: 11171447/ UDI: 07613203021234; REF: 11532269/ UDI: 10885403232343; REF: 10010454/ UDI: 07613203015806; REF: 2465-0007/ UDI: 10885403221941; REF: 10010453/ UDI: 07613203021135 REF: 11419365/ UDI: 10885403234736 REF: 10813621/UDI: 10885403234514 REF: 2423-0007/UDI: 07613203020985 REF: 10015896/UDI: 10885403234064 REF: 24010-0007T/UDI: 10885403271021 REF: 10010483/UDI: 10885403232602 REF: 2403-0007/UDI: 10885403232473 REF: 24301-0007T/UDI: 10885403223198	Not provided in the normalized record	Ongoing
Z-2179-2025	Z-2179-2025	BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046	Not provided in the normalized record	Ongoing

Distribution: US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Jul 8, 2025
Recall initiated
Date recorded by the FDA.
Aug 6, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 97067
Published: Aug 6, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Loading MedWatcher information…

BD Alaris Infusion System recall — FDA event 97067

FDA · FDA event 97067 · Posted Aug 6, 2025

Published Aug 6, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

Products affected by FDA event 97067
Model	Description	Lot / serial range	Manufactured	Status
Z-2180-2025	Z-2180-2025	REF: 10013186/ UDI: 07613203021173; REF: 2452-0007/ UDI: 10885403219870; REF: 2204-0007/ UDI: 10885403199363; REF: 24001-0007/ UDI: 10885403238666; REF: 10015012/ UDI: 10885403233951; REF: 2432-0007/ UDI: 10885403232329; REF: 2434-0007/ UDI: 07613203019682; REF: 2202-0007/ UDI: 10885403274039; REF: 11426965/ UDI: 10885403232558; REF: 10561554/ UDI: 10885403232565; REF: 10863358/ UDI: 10885403232466; REF: 11171447/ UDI: 07613203021234; REF: 11532269/ UDI: 10885403232343; REF: 10010454/ UDI: 07613203015806; REF: 2465-0007/ UDI: 10885403221941; REF: 10010453/ UDI: 07613203021135 REF: 11419365/ UDI: 10885403234736 REF: 10813621/UDI: 10885403234514 REF: 2423-0007/UDI: 07613203020985 REF: 10015896/UDI: 10885403234064 REF: 24010-0007T/UDI: 10885403271021 REF: 10010483/UDI: 10885403232602 REF: 2403-0007/UDI: 10885403232473 REF: 24301-0007T/UDI: 10885403223198	Not provided in the normalized record	Ongoing
Z-2179-2025	Z-2179-2025	BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046	Not provided in the normalized record	Ongoing

Distribution

US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey

Units affected

See official FDA record

BD Alaris System with Guardrails Suite MX recall — FDA event 98250

Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units

FDA · FDA event 98250Posted Mar 26, 2026BD Alaris Infusion System

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BD Alaris Infusion System recall — FDA event 97669

FDA · FDA event 97669Posted Nov 20, 2025BD Alaris Infusion System

Class I recallOngoing

BD Alaris Infusion System recall — FDA event 96323

Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).

FDA · FDA event 96323Posted Mar 13, 2025BD Alaris Infusion System

BD Alaris Infusion System recall — FDA event 97067

Follow BD Alaris Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

BD Alaris Infusion System recall — FDA event 97067

Follow BD Alaris Infusion System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline