CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report

smiths medical Cadd-Solis Li-ion Rechargeable Battery Packs recalled

Smiths Medical ASD is recalling smiths medical Cadd-Solis Li-ion Rechargeable Battery Packs AC adapter. The recall was initiated on 26 Jun 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 21-0270-25, UDI/DI 15019517126844, All lots
Quantity recalled156,400 AC adapters

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-0466-2025
FDA event ID
95483
Recalling firm
Smiths Medical ASD, Minneapolis, MN
Classification
Class II
Status
Ongoing
Recall initiated
26 Jun 2024
FDA classified
15 Nov 2024
Reported
27 Nov 2024
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Foreign Material
Device type
Infusion Pumps

Timeline

26 Jun 2024Recall initiated by company
15 Nov 2024Classified by FDA+142 days
27 Nov 2024Published in enforcement report+12 days

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

Reason for recall

The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps

Where it was distributed

Worldwide distribution.

Questions about this recall

Is smiths medical Cadd-Solis Li-ion Rechargeable Battery Packs AC adapter recalled?

Yes. Smiths Medical ASD recalled smiths medical Cadd-Solis Li-ion Rechargeable Battery Packs AC adapter on 26 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-0466-2025.

Why was it recalled?

The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.

Which lots are affected?

Model 21-0270-25, UDI/DI 15019517126844, All lots

Where was it sold?

Worldwide distribution.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

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