CADD" Medication Cassette Reservoir — Class II medical device recall Z-1286-2015
Terminated recall by Smiths Medical ASD, Inc., reported 2015-03-25, distributed nationwide. Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs (
| Recall number | Z-1286-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Saint Paul, MN, United States |
| Recall initiated | 2015-02-02 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-03-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CO, CZ, DE, DK, ES, FI, FR, GB, HU, ID, IE, IT, NL, PT, SE, SG, ZA |
| Reason classes | packaging |
| Lot numbers | 14X297, 14X323, 14X324, 21-7301-24 |
| Model numbers | 21-7001-24, 21-7301-24 |
Product
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Reason for recall
Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette Reservoirs ( Cassette ). Some Cassettes may leak at the sealing area of the pump tube and medication bag. Smiths Medical has received no reports of serious injury or death related to this issue.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1286-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.