Becton, Dickinson and Company

MedWatcher tracks the reviewed device family BD Alaris Infusion System under the canonical manufacturer identity Becton, Dickinson and Company. The recall records on this page are limited to 8 owner-approved FDA recall actions.

What MedWatcher tracks

This page covers only the reviewed device families and FDA recall actions shown below. It is not a complete product catalogue, and a recall does not necessarily affect every unit or configuration in a device family.

Reviewed device families: 1
Matched recall actions: 8
Source records last checked: Oct 8, 2026

Manufacturer identity and source matching

The manufacturer and device-family relationships come from the reviewed canonical-device inventory. Recall coverage is limited to the exact candidate IDs approved and published in the FUS-265 cohort; complete regulator payloads remain in the private source ledger.

Source databases can use a legal name, brand, division, or shortened name. MedWatcher retains the form used as evidence rather than treating every similar name as the same manufacturer.

Baxter Healthcare CorporationSource-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)
CareFusion 303, Inc.Source-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)
CareFusion 303, Inc.Source-name variantReviewed openFDA recalling-firm identity — FUS-265Evidence source (opens in a new tab)

Sources used for this page

U.S. Food and Drug AdministrationFDA medical device recall recordsLast checked Aug 16, 2026 openFDAMedical device recall bulk dataLast checked Aug 16, 2026

Page reviewed Aug 17, 2026 by fusiondesigner@gmail.com · Next review by Nov 17, 2026.

Infusion pumps

View category

BD Alaris Infusion System

Becton, Dickinson and Company · Infusion pumps

Active recall record

Last checked Oct 8, 2026

Recent recall records

Class II recallOngoing

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 II recallOngoing

BD Alaris" Pump Module model 8100 recall — FDA event 97871

Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid…

FDA · FDA event 97871Posted Jan 29, 2026

Class I recallOngoing

BD Alaris Infusion System recall — FDA event 97669

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,…

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

Class I recallOngoing

BD Alaris Infusion System recall — FDA event 97067

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.

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

Class II recallOngoing

BD Alaris Infusion System recall — FDA event 96069

Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.

FDA · FDA event 96069Posted Feb 24, 2025BD Alaris Infusion System

Class II recallOngoing

BD Alaris Infusion System recall — FDA event 94937

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

FDA · FDA event 94937Posted Sep 13, 2024BD Alaris Infusion System

Class I recallOngoing

BD Alaris Infusion System recall — FDA event 93106

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

FDA · FDA event 93106Posted Nov 7, 2023BD Alaris Infusion System

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Recent recall records

Class II recallOngoing

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 II recallOngoing

BD Alaris" Pump Module model 8100 recall — FDA event 97871

FDA · FDA event 97871Posted Jan 29, 2026

Class I recallOngoing

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 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

Class II recallOngoing

BD Alaris Infusion System recall — FDA event 96069

FDA · FDA event 96069Posted Feb 24, 2025BD Alaris Infusion System

Class II recallOngoing

BD Alaris Infusion System recall — FDA event 94937

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

FDA · FDA event 94937Posted Sep 13, 2024BD Alaris Infusion System

Class I recallOngoing

BD Alaris Infusion System recall — FDA event 93106

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

FDA · FDA event 93106Posted Nov 7, 2023BD Alaris Infusion System

Becton, Dickinson and Company

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What MedWatcher tracks

Manufacturer identity and source matching

Sources used for this page

Infusion pumps

BD Alaris Infusion System

Recent recall records

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

BD Alaris" Pump Module model 8100 recall — FDA event 97871

BD Alaris Infusion System recall — FDA event 97669

BD Alaris Infusion System recall — FDA event 97067

BD Alaris Infusion System recall — FDA event 96323

BD Alaris Infusion System recall — FDA event 96069

BD Alaris Infusion System recall — FDA event 94937

BD Alaris Infusion System recall — FDA event 93106

Becton, Dickinson and Company

Follow Becton, Dickinson and Company

What MedWatcher tracks

Manufacturer identity and source matching

Sources used for this page

Infusion pumps

BD Alaris Infusion System

Recent recall records

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

BD Alaris" Pump Module model 8100 recall — FDA event 97871

BD Alaris Infusion System recall — FDA event 97669

BD Alaris Infusion System recall — FDA event 97067

BD Alaris Infusion System recall — FDA event 96323

BD Alaris Infusion System recall — FDA event 96069

BD Alaris Infusion System recall — FDA event 94937

BD Alaris Infusion System recall — FDA event 93106