Key facts
| Recalling firm | BD SWITZERLAND SARL |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 11171447* 7613203021234 37613203021242 BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites 11426965* 10885403232558 50885403232556 BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sites 2260-0500 7613203012591 37613203012608 BD Alaris Pump Infusion Set, PE Lined Tubing 24600-0007 10885403241970 50885403241978 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 2278-0500 10885403223266 50885403223264 BD Alaris Pump Infusion Blood Set, 200 Micron Filter 2477-0007 7613203019460 37613203019478 BD Alaris Pump Infusion Blood Set, 180 Micron Filter, SmartSite Y-site 22603-B007T 10885403240942 50885403240940 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 24010-0007T 10885403271021 50885403271029 BD Alaris Pump Infusion Set, Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite Y-sites 24301-0007T 10885403223198 50885403223196 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, SmartSite Y-site 24601-B007T 10885403240959 50885403240957 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, Back Check Valve, 2 SmartSite Y- sites 22602-B007T 10885403240935 50885403240933 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 11426964 10885403232367 50885403232365 BD Alaris¿LVP 20D LOW SORB 2204-0007* 10885403199363 50885403199361 BD Alaris Pump Infusion Set 10015862 10885403221866 50885403221864 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing 10010453 7613203021135 37613203021143 BD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 11532269 10885403232343 50885403232341 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sites 2202-0007* 10885403274039 50885403274037 BD Alaris Pump Infusion Set, 1.2 Micron Filter 2432-0007* 10885403232329 50885403232327 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10010454 7613203015806 37613203015814 BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 2465-0007 10885403221941 50885403221949 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 10015012 10885403233951 50885403233959 BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-site 2441-0007 10885403235047 50885403235045 BD Alaris Pump Infusion Burette Set, Smallbore Tubing, SmartSite Port (Burette), 3 SmartSite Y-sites 11419365 10885403234736 50885403234734 BD Alaris Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite Y-sites 2423-0007 7613203020985 37613203020979 BD Alaris Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10813621 10885403234514 50885403234512 BD Alaris Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10010483 10885403232602 50885403232600 BD Alaris Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing 10013072 7613203021210 37613203021228 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 2 SmartSite Y-sites 10013361 10885403221965 50885403221963 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Back Check Valve, 2 SmartSite Y-sites 10013890 10885403232268 50885403232266 BD Alaris Pump Infusion Set, PE Lined Tubin |
| Classification | Class I |
| Recall number | Z-3080-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance. |
What this classification means
A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.
What consumers should do
Facilities, clinicians, and consumers holding an affected unit or lot of BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 11171447* 7613203021234 37613203021242 BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites 11426965* 10885403232558 50885403232556 BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sites 2260-0500 7613203012591 37613203012608 BD Alaris Pump Infusion Set, PE Lined Tubing 24600-0007 10885403241970 50885403241978 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 2278-0500 10885403223266 50885403223264 BD Alaris Pump Infusion Blood Set, 200 Micron Filter 2477-0007 7613203019460 37613203019478 BD Alaris Pump Infusion Blood Set, 180 Micron Filter, SmartSite Y-site 22603-B007T 10885403240942 50885403240940 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 24010-0007T 10885403271021 50885403271029 BD Alaris Pump Infusion Set, Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite Y-sites 24301-0007T 10885403223198 50885403223196 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, SmartSite Y-site 24601-B007T 10885403240959 50885403240957 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, Back Check Valve, 2 SmartSite Y- sites 22602-B007T 10885403240935 50885403240933 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 11426964 10885403232367 50885403232365 BD Alaris¿LVP 20D LOW SORB 2204-0007* 10885403199363 50885403199361 BD Alaris Pump Infusion Set 10015862 10885403221866 50885403221864 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing 10010453 7613203021135 37613203021143 BD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 11532269 10885403232343 50885403232341 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sites 2202-0007* 10885403274039 50885403274037 BD Alaris Pump Infusion Set, 1.2 Micron Filter 2432-0007* 10885403232329 50885403232327 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10010454 7613203015806 37613203015814 BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 2465-0007 10885403221941 50885403221949 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 10015012 10885403233951 50885403233959 BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-site 2441-0007 10885403235047 50885403235045 BD Alaris Pump Infusion Burette Set, Smallbore Tubing, SmartSite Port (Burette), 3 SmartSite Y-sites 11419365 10885403234736 50885403234734 BD Alaris Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite Y-sites 2423-0007 7613203020985 37613203020979 BD Alaris Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10813621 10885403234514 50885403234512 BD Alaris Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10010483 10885403232602 50885403232600 BD Alaris Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing 10013072 7613203021210 37613203021228 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 2 SmartSite Y-sites 10013361 10885403221965 50885403221963 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Back Check Valve, 2 SmartSite Y-sites 10013890 10885403232268 50885403232266 BD Alaris Pump Infusion Set, PE Lined Tubin should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from BD SWITZERLAND SARL. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from BD SWITZERLAND SARL should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to BD SWITZERLAND SARL directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.
BD SWITZERLAND SARL’s FDA history
Argus HQ has recorded 4 total FDA actions tied to BD SWITZERLAND SARL: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What is the FDA recall number for this event?
- FDA recall number Z-3080-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
- Is BD Alaris Pump Infusion Sets 10561554* 10885403232565 508854 recalled?
- Yes. FDA lists a Class I recall by BD SWITZERLAND SARL for BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 11171447* 7613203021234 37613203021242 BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sites 11426965* 10885403232558 50885403232556 BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sites 2260-0500 7613203012591 37613203012608 BD Alaris Pump Infusion Set, PE Lined Tubing 24600-0007 10885403241970 50885403241978 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 3 SmartSite Y-sites 2278-0500 10885403223266 50885403223264 BD Alaris Pump Infusion Blood Set, 200 Micron Filter 2477-0007 7613203019460 37613203019478 BD Alaris Pump Infusion Blood Set, 180 Micron Filter, SmartSite Y-site 22603-B007T 10885403240942 50885403240940 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 24010-0007T 10885403271021 50885403271029 BD Alaris Pump Infusion Set, Bonded Texium, Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite Y-sites 24301-0007T 10885403223198 50885403223196 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, SmartSite Y-site 24601-B007T 10885403240959 50885403240957 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap, Back Check Valve, 2 SmartSite Y- sites 22602-B007T 10885403240935 50885403240933 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 11426964 10885403232367 50885403232365 BD Alaris¿LVP 20D LOW SORB 2204-0007* 10885403199363 50885403199361 BD Alaris Pump Infusion Set 10015862 10885403221866 50885403221864 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing 10010453 7613203021135 37613203021143 BD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 11532269 10885403232343 50885403232341 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sites 2202-0007* 10885403274039 50885403274037 BD Alaris Pump Infusion Set, 1.2 Micron Filter 2432-0007* 10885403232329 50885403232327 BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10010454 7613203015806 37613203015814 BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 2465-0007 10885403221941 50885403221949 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-site 10015012 10885403233951 50885403233959 BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-site 2441-0007 10885403235047 50885403235045 BD Alaris Pump Infusion Burette Set, Smallbore Tubing, SmartSite Port (Burette), 3 SmartSite Y-sites 11419365 10885403234736 50885403234734 BD Alaris Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite Y-sites 2423-0007 7613203020985 37613203020979 BD Alaris Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10813621 10885403234514 50885403234512 BD Alaris Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite Y-sites 10010483 10885403232602 50885403232600 BD Alaris Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing 10013072 7613203021210 37613203021228 BD Alaris Pump Infusion Set, PE Lined Tubing, Back Check Valve, 2 SmartSite Y-sites 10013361 10885403221965 50885403221963 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Back Check Valve, 2 SmartSite Y-sites 10013890 10885403232268 50885403232266 BD Alaris Pump Infusion Set, PE Lined Tubin, reported 20260923, with status "Ongoing." FDA recall number: Z-3080-2026.
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Full FDA history for BD SWITZERLAND SARLCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class I Recall: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563… by BD SWITZERLAND SARL — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/bd-switzerland-sarl-z-3080-2026-2026-09-23
"FDA Class I Recall: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563… by BD SWITZERLAND SARL — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/bd-switzerland-sarl-z-3080-2026-2026-09-23.
Argus HQ Research. "FDA Class I Recall: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563… by BD SWITZERLAND SARL — Recall Details." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/recall/bd-switzerland-sarl-z-3080-2026-2026-09-23.
@misc{argushq_argushq_ai_recall_bd_switzerland_sarl_z_3080_2026_2026_09_23_2026,
title = {FDA Class I Recall: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563… by BD SWITZERLAND SARL — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/bd-switzerland-sarl-z-3080-2026-2026-09-23},
note = {Accessed: September 29, 2026}
}Source: FDA.gov — Recalls ↗