Recall Register

Food, drugs, devices › CareFusion 303, Inc.

Device recall: Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169

FDA enforcement event 97245 · Class III · initiated 10 Jul 2025 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordSan Diego, CA

CareFusion 303, Inc. (San Diego, CA) initiated this device recall on 10 Jul 2025; FDA lists 1 product record under event 97245, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 2% of the 945 device enforcement events initiated in 2025 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. CareFusion 303, Inc. has 99 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

CareFusion 303, Inc., San Diego, CA.

Reason for recall

"Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow."

Distribution

"US Nationwide distribution including in the states of NY, MA, KY, VA, OR, OH, FL, WA, MS, OK, TN, PA, RI, TX, SC, AR, MI, NJ, CT, MD, AZ, CA, WV, NC, UT, WY, CO, SD, ID, IL, IN, NV, NM, NE, KS, GA,…"

Product records

Recall numberProductQuantityClassStatusReport date
Z-2321-2025Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-2HM/169-108, BD PYXIS MEDBANK MINI…6076Class IIIOngoing20 Aug 2025

Context

2%of 2025 device events are Class III945 events that year
1product record in this eventfirm median: 1
99events on this register for the firm

Other enforcement events for CareFusion 303, Inc.

InitiatedProduct (first record)TypeClassRecords
30 Apr 2026BD Pyxis MedStation 4000 REF: 303 Medication cabinetDeviceClass II8
11 Feb 2026BD Alaris" System with Guardrails" Suite MX with Point of Care UnitDeviceClass II1
3 Dec 2025BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 1DeviceClass II1
20 Nov 2025BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REFDeviceClass II1
6 Nov 2025BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a moduDeviceClass II1
17 Oct 2025BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REDeviceClass I1
30 Sep 2025Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 13890DeviceClass II5
11 Sep 2025BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron FiDeviceClass I1
8 Jul 2025BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versionsDeviceClass I2
8 May 2025Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4DeviceClass II1

All 99 events for CareFusion 303, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution including in the states of NY, MA, KY, VA, OR, OH, FL, WA, MS, OK, TN, PA, RI, TX, SC, AR, MI, NJ, CT, MD, AZ, CA, WV, NC, UT, WY, CO, SD, ID, IL, IN, NV, NM, NE, KS, GA,…"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.