BD Alaris Pump Infusion Sets for the following reference numbers:… — Class I medical device recall Z-0035-2026
Ongoing recall by CareFusion 303, Inc., reported 2025-10-15, distributed nationwide. Infusion pump module used with compatible pump infusion sets may perform outside the established performance r
| Recall number | Z-0035-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2025-09-11 |
| Classified | 2025-10-08 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BH, CA, CH, CN, FR, GB, IL, IN, KW, MX, MY, NL, NZ, PH, PK, QA, SA, SG, TW, ZA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07613203012492, 07613203020992, 07613203021159, 10885403232305, 10885403232312, 10885403233753, 10885403233784, 10885403233999, 10885403235078, 10885403235528, 10885403239588, 10885403276026, 10885403463969, 10885403476341 |
Product
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented, SmartSite Y-site 2426-0500, Back Check Valve, 3 SmartSite Y-sites 2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500, 2 SmartSite Y-Sites 2232-0007, 0.2 Micron Filter 11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites 10012144, 3 SmartSite Y-Sites, Check Valve 10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock
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.
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-0035-2026. 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.