FDA · Class I · September 23, 2026
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
BD Switzerland Sarl recall: BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump…
BD Switzerland Sarl is recalling BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump… – 94,230,757. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on August 19, 2026. Distributed nationwide.
Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.
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| Product | BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump… |
| Brand | BD Switzerland Sarl |
| Type | Medical devices |
| Classification | Class I |
| Recall date | August 19, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 94,230,757 |
| Recall ID | 99298 |
As listed by FDA
Recalled products
- 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
- FDA recall number
- Z-3080-2026
- Codes, lots and dates
- 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 Tubing 10015645 10885403227967 50885403227965 BD Alaris Pump Infusion Set 2 SmartSite Y-Sites 295 cm (116 in) 10062818 7613203019668 37613203019676 BD Alaris Pump Infusion Blood Set, 180 Micron Filter, 2 Blunt Spikes 10821753 7613203019187 37613203019195 BD Alaris Pump Infusion Burette Set, SmartSite Port (Burette), 3 SmartSite Y-sites 11404930 7613203021197 37613203021204 BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites 10013361T 10885403223204 50885403223202 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Bonded Texium Closed Male, Luer with Priming Cap, Back Check Valve, 2 SmartSite Y-sites 10321213T 10885403228971 50885403228979 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, Bonded Texium Closed Male Luer with priming cap 2120-0500 7613203012690 37613203012707 BD Alaris Pump Infusion Set, Back Check Valve, 2 VersaSafe Split Septum Y-sites 2200-0500 7613203012638 37613203012646 GEM V/NV PRIMARY 20DP 22000-B007T 10885403245022 50885403245020 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 2203-0500 7613203019200 37613203019218 BD Alaris Pump Infusion Set, 15 Micron Filter, Amber Tubing 2210-0500 7613203012614 37613203012622 GEM V/NV PRI W/2 INJ SITES 20 22600-0007T 10885403239595 50885403239593 BD Alaris Pump Infusion Set, PE Lined Tubing, Bonded Texium Closed Male Luer with Priming Cap 2408-0500 10885403235030 50885403235038 GEM 10DP CKV 4WAY-STPCK 4SS 2420-0500 7613203012430 37613203012448 BD Alaris Pump Infusion Set, Back Check Valve, 2 SmartSite Y-sites 2428-0007 10885403220883 50885403220881 BD Alaris Pump Infusion Set, 2 Back Check Valves, 4 SmartSite Y-sites 2455-0500 7613203021296 37613203021303 BD Alaris Pump Infusion Set, SmartSite Y-site 2466-0007 10885403221958 50885403221956 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing 2206-0007 7613203019224 37613203019232 BD Alaris Pump Infusion Set, Yellow-Striped Microbore Tubing
- Quantity
- 94,230,757
- Classification
- Class I
Exactly as the agency lists them
Identifiers and details
- FDA event ID
- 99298
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Eysins, N/A, Switzerland
Why it was recalled
The reason the FDA lists: “Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.”
Where it was sold
Nationwide. Distribution as the FDA records it: “U.S.: Nation-wide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia Belgium Bahrain Botswana Canada Cuba China France Germany Gibraltar Israel India Italy Japan Korea, Republic of Kuwait Mexico Malaysia Netherlands New Zealand Philippines Pakistan Qatar Saudi Arabia Singapore South Africa Switzerland Taiwan, Province of China Turkey United Arab Emirates United Kingdom”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99298, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Same brand
Other BD Switzerland Sarl recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Aug 19, 2026 |  BD Switzerland Sarl recall: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext…Medical devices · 93,700 | Products may not have received adequate sterilization processing. Serious | FDA Class II |
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FAQ
About this recall
Is BD Switzerland Sarl BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump… recalled?
Yes. BD Switzerland Sarl recalled it on August 19, 2026; FDA published it September 23, 2026 (Class I). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
Recalls
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.