CLASS I ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report

BD Alaris Pump Module recalled by CareFusion 303

CareFusion 303 is recalling BD Alaris Pump Module, distributed nationwide in the US. The recall was initiated on 8 Jul 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesBD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046

Quantity recalled33,162,680 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2179-2025
FDA event ID: 97067
Recalling firm: CareFusion 303, San Diego, CA
Classification: Class I
Status: Ongoing
Recall initiated: 8 Jul 2025
FDA classified: 6 Aug 2025
Reported: 13 Aug 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

8 Jul 2025	Recall initiated by company
6 Aug 2025	Classified by FDA	+29 days
13 Aug 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

Where it was distributed

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

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Is BD Alaris Pump Module recalled?

Yes. CareFusion 303 recalled BD Alaris Pump Module on 8 Jul 2025. The recall is Class I and its status is Ongoing. Recall number Z-2179-2025.

Why was it recalled?

Which lots are affected?

BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from CareFusion 303

All 143

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	BD Pyxis MedStation ES Tower recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	BD Pyxis MedBank Mini recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	BD Pyxis MedStation recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	BD Pyxis Anesthesia Station ES recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	BD Pyxis MedStation ES recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide

Other Medical Software recalls

All 903

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Philips Brilliance recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips IQon Spectral CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Ingenuity CT Product Codes recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel Product recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide