Class I recallOngoing

BD Alaris Infusion System recall — FDA event 97669

FDA · FDA event 97669 · Posted Nov 20, 2025

Published Nov 20, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

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 10/17/2025, correction notices were mailed and emailed:
Distribute notice to clinical and non-clinical users. Safety Reminder: https://academy.bd.com/en-us/home.
Provide notice to any facilities you may have sold or transferred devices to. Use only BD-authorized companies when renting infusion devices. Complete and return response form to bdrc55@bd.com
If dropped, biomedical engineering should perform testing as specified in Level of Testing Guidelines, including rate accuracy verification testing. If any test fails see troubleshooting section, see Technical Service Manual, Chapter 5 and 6. User Manuals: https://bd.com/self-service.
Firm contacts: Technical Support 888-812-3229, DL-US-INF-TechSupport@bd.com . Product Complaints: ProductComplaints@bd.com
BD Alaris Infusion System Safety Reminder: To ensure system remains in good operating condition, if a device or accessory is dropped or severely jarred, take the device out of use. Even if no visible damage is present, internal components may be affected. Return the device to Biomedical Engineering for inspection and repair. Visually inspect the system before each use. Check all visible surfaces and moving parts and if you observe damage or find the device does not function as expected, return it to biomedical engineering for repair. Do not use a device that appears to be damaged or does not function as expected. Return device to Biomedical Engineering for repair. Only biomedical engineering should perform annual maintenance as specified in the System Maintenance Software User Manual. Important in ensuring regular testing of any potentially dropped or damaged device that was not immediately removed from use to prevent infusion errors, protect patient safety, and promote proper function. All should understand the potential safety risks associated with using a device that may have sustained damage.

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 97669
Model	Description	Lot / serial range	Manufactured	Status
Z-0430-2026	Z-0430-2026	All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743	Not provided in the normalized record	Ongoing

Distribution: Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Oct 17, 2025
Recall initiated
Date recorded by the FDA.
Nov 20, 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: 97669
Published: Nov 20, 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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BD Alaris Infusion System recall — FDA event 97067

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Loading MedWatcher information…

BD Alaris Infusion System recall — FDA event 97669

FDA · FDA event 97669 · Posted Nov 20, 2025

Published Nov 20, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 97669
Model	Description	Lot / serial range	Manufactured	Status
Z-0430-2026	Z-0430-2026	All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743	Not provided in the normalized record	Ongoing

Distribution

Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR.

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

Class I recallOngoing

BD Alaris Infusion System recall — FDA event 97067

FDA · FDA event 97067Posted Aug 6, 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 97669

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 97669

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