CareFusion 303, Inc. recall records

103 reported ongoing

103 records in this archive. Latest source date Apr 30, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

BD Alaris" System with Guardrails" Suite MX with Point of Care Unit

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

Class IIReported ongoing

Distribution: Worldwide distribution: U.S.(Nationwide) to states of: AL, AR, 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...

Official source for BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
FDA device enforcement

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139...

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

Class IIReported ongoing

Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK,AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,...

Official source for BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, ...
FDA device enforcement

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD ...

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or d...

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution including in the states of CO, IN, OH, TX, KS, FL, GA, NC, CA, HI, IL, NY, MI, VA, AL, LA, NE, KY, OK, AR, TN, WY, NJ, WI, SD, AZ, NV, MO,...

Official source for BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis M...
FDA device enforcement

BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuou...

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...

Class IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of AZ, IN, OH, and VA.

Official source for BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardra...
FDA device enforcement

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated docu...

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, ...

Class IReported 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,...

Official source for BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY O...
FDA device enforcement

Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 138905-01 138906-01 138907-01 138908-01 138909-01 138910-01 13...

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

Official source for Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 13...
FDA device enforcement

Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052...

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

Official source for Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040...
FDA device enforcement

BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0...

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.

Class IReported ongoing

Distribution: US: Nationwide OUS: United Arab Emirates Australia Belgium Bahrain Botswana Canada Switzerland China France United Kingdom Gibraltar Israel India Kuwait Mexico Malaysia Netherla...

Official source for BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micro...
FDA device enforcement

Description/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 MED...

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

Class IIIReported ongoing

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,...

Official source for Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYX...

Reasons in these listed records

  • Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
  • 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
  • Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
  • Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing st...

These examples come from this result page and are not a ranking of every recall reason.

Checking CareFusion 303, Inc.

Is there a recall on carefusion 303, inc. right now?

This archive contains 103 records, including 103 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking