smiths medical CADD-Solis Li-ion Rechargeable Battery Packs… recallZ-0466-2025 · Smiths Medical ASD, Inc. · initiated Jun 26, 2024
Class II Open, Classified All recalls posted in November 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
Smiths Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 06/26/2024 via letter distributed by a traceable means. The notice explained the issue, potential risk, and requested the following: Locate all Model 21-0270-25 AC Adapters in your possession. Inspect the AC Adapter for damage to the input plug, missing AC prongs, or exposed metal contacts. If damaged, remove the AC Adapter from service and submit a request for credit to Smiths Medical at 800-258-5361. Distributors were directed to forward to the notice to those to whom the they distributed the device with the request to complete the response form and return it to [email protected].
Recall details
- Recall number
- Z-0466-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jun 26, 2024
- Posted by the FDA
- Nov 15, 2024
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 156,400 AC adapters
- Product code
- MEA
- FDA submissions
- K170982, K111275
- Distribution
- Worldwide distribution.
Product description
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
Code information (models, lots, serial numbers)
Model 21-0270-25, UDI/DI 15019517126844, All lots
Other devices under the same FDA submission
37 devices cleared under K170982, K111275 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CADD 21-2120-0105-01Icu Medical, Inc. · Pump, infusion4 recalls3 deaths5,914 reports
- CADD 2120Icu Medical, Inc. · Pump, infusion2 recalls6 deaths4,097 reports
- CADD 21-2120-0102-51Icu Medical, Inc. · Pump, infusion4 recalls2 deaths3,555 reports
- CADD 21-2111-0402-51Icu Medical, Inc. · Pump, infusion, pca4 recalls1,535 reports
- CADD 21-2127-0105-01Icu Medical, Inc. · Pump, infusion2 recalls1,466 reports
- CADD 2120Icu Medical, Inc. · Pump, infusion2 recalls3 deaths1,256 reports
- CADD 21-2120-0103-51Icu Medical, Inc. · Pump, infusion2 recalls1 death1,107 reports
- CADD 21-2120-0103-01Icu Medical, Inc. · Pump, infusion4 recalls585 reports
- CADD 21-2111-0401-51Icu Medical, Inc. · ACCESSORIES, PUMP, INFUSION4 recalls461 reports
- CADD 21-2112-0402-51Icu Medical, Inc. · Neuraxial Administration Set - Intrathecal delivery3 recalls469 reports
- CADD 21-2120-0102-02Icu Medical, Inc. · Pump, infusion3 recalls381 reports
- CADD 21-2111-0400-51Icu Medical, Inc. · Pump, infusion4 recalls124 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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