CLASS I ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
Cadd-Solis Li-ion Rechargeable Battery Packs recalled
Smiths Medical ASD is recalling Cadd-Solis Li-ion Rechargeable Battery Packs. The recall was initiated on 16 Jul 2024 and the FDA has classified it as Class I.
Check your package
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-0222-2025
- FDA event ID
- 95287
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 16 Jul 2024
- FDA classified
- 31 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 16 Jul 2024 | Recall initiated by company | |
| 31 Oct 2024 | Classified by FDA | +107 days |
| 6 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.
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
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238, 21-2101-249, 21-2101-51, 21-2102-0200-02, 21-2102-249, 21-2102-51, 21-2111-0100-00, 21-2111-0100-50, 21-2111-0100-51, 21-2111-0200-02, 21-2111-0200-03, 21-2111-0200-06, 21-2111-0200-07, 21-2111-0200-08, 21-2111-0200-12, 21-2111-0200-14, 21-2111-0200-17, 21-2111-0200-232, 21-2111-0200-50, 21-2111-0300-00, 21-2111-0300-01, 21-2111-0300-02, 21-2111-0300-03, 21-2111-0300-06, 21-2111-0300-07, 21-2111-0300-08, 21-2111-0300-09, 21-2111-0300-12, 21-2111-0300-14, 21-2111-0300-17, 21-2111-0300-231, 21-2111-0300-232, 21-2111-0300-50, 21-2111-0400-01, 21-2111-0400-51, 21-2111-0401-02L, 21-2111-0401-03L, 21-2111-0401-06L, 21-2111-0401-07, 21-2111-0401-07L, 21-2111-0401-08L, 21-2111-0401-12L, 21-2111-0401-14L, 21-2111-0401-17L, 21-2111-0401-249, 21-2111-0401-51, 21-2111-0401-51L, 21-2111-0401-78, 21-2111-0402-02, 21-2111-0402-02L, 21-2111-0402-03L, 21-2111-0402-06L, 21-2111-0402-07L, 21-2111-0402-08, 21-2111-0402-08L, 21-2111-0402-09_LOAN, 21-2111-0402-09-FUK, 21-2111-0402-09JP, 21-2111-0402-09-KYO, 21-2111-0402-09-NAG, 21-2111-0402-09-OKA, 21-2111-0402-09-OSA, 21-2111-0402-09-SAP, 21-2111-0402-09-SEN, 21-2111-0402-09-TOKE, 21-2111-0402-09-TOKW, 21-2111-0402-09-YOK, 21-2111-0402-12L, 21-2111-0402-14L, 21-2111-0402-17L, 21-2111-0402-249, 21-2111-0402-51, 21-2111-0402-51L, 21-2111-0402-78, 21-2112-0100-50, 21-2112-0100-51, 21-2112-0200-02, 21-2112-0200-06, 21-2112-0300-00, 21-2112-0300-01, 21-2112-0300-02, 21-2112-0300-03, 21-2112-0300-06, 21-2112-0300-231, 21-2112-0300-50, 21-2112-0400-01, 21-2112-0400-51, 21-2112-0401-02L, 21-2112-0401-03L, 21-2112-0401-07L, 21-2112-0401-08L, 21-2112-0401-17L, 21-2112-0401-51, 21-2112-0401-51L, 21-2112-0401-78, 21-2112-0402-02, 21-2112-0402-02L, 21-2112-0402-03L, 21-2112-0402-06L, 21-2112-0402-07L, 21-2112-0402-08L, 21-2112-0402-09JP, 21-2112-0402-09-SAI, 21-2112-0402-09-SEN, 21-2112-0402-09-TOKE, 21-2112-0402-17L, 21-2112-0402-249, 21-2112-0402-51, 21-2112-0402-51L, 21-2120-0100-02, 21-2120-0100-03, 21-2120-0100-06, 21-2120-0100-232, 21-2120-0100-233, 21-2120-0100-50, 21-2120-0100-51, 21-2120-0100-95, 21-2120-0102-02, 21-2120-0102-03, 21-2120-0102-06, 21-2120-0102-07, 21-2120-0102-08, 21-2120-0102-12, 21-2120-0102-13, 21-2120-0102-14, 21-2120-0102-15, 21-2120-0102-17, 21-2120-0102-247, 21-2120-0102-249, 21-2120-0102-51, 21-2120-0102-78, 21-2120-0102-92, 21-2120-0102-98, 21-2120-0103-01, 21-2120-0103-02, 21-2120-0103-03, 21-2120-0103-06, 21-2120-0103-07, 21-2120-0103-08, 21-2120-0103-14, 21-2120-0103-15, 21-2120-0103-17, 21-2120-0103-249, 21-2120-0103-51, 21-2120-0103-78, 21-2120-0104-01, 21-2120-0105-00, 21-2120-0105-01, 21-2120-0105-02L, 21-2120-0105-03L, 21-2120-0105-06L, 21-2120-0105-07L, 21-2120-0105-08L, 21-2120-0105-12L, 21-2120-0105-13L, 21-2120-0105-14L, 21-2120-0105-15L, 21-2120-0105-17L, 21-2120-0105-231, 21-2120-0105-50, 21-2120-0105-50L, 21-2125-0104-01, 21-2125-0105-07L, 21-2125-0105-08L, 21-2125-0105-50L, 21-2127-0104-01, 21-2127-0105-01, 21-2127-0105-02L, 21-2127-0105-03L, 21-2127-0105-06L, 21-2127-0105-08L, 21-2127-0105-50L, 22-4095-0203-51, 22-4095-0204-25, 22-4095-0205-25.
Where it was distributed
Worldwide Distribution
Questions about this recall
Why was it recalled?
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.
Which lots are affected?
All serial numbers.
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 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 26 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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