BD Alaris Pump Infusion Sets recallZ-3080-2026 · Bd Switzerland Sarl · initiated Aug 19, 2026

Why it was recalled

Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.

FDA root cause category: Device Design

What the company is doing

On 08/19/2026, an "URGENT MEDICAL DEVICE CORRECTION" letter was sent via FedEx and other courier services informing customers that, the BD Alaris" Pump Module Model 8100, when used with some BD Alaris" Pump Infusion Sets at low flow rates or to deliver low bolus volumes, may perform worse than previously disclosed. Due to the difficulty in recognizing these performance issues, users may fail to identify them as the cause of clinically significant changes in a patient's condition. Performance attributes that differ from previously communicated values have the potential to result in greater degrees of under / overinfusion, delayed time to occlusion alarms, and bolus dose inaccuracies. The Recall Notificaiton provides Clinical Recommendations for Sets with Updated Performance. Customers are instructed to: Immediately discard any sets listed within Attachment C: Discontinued Alaris" Pump Sets per your facility s procedures. a. To receive credit for discarded product, please return the completed Customer Response Form attached to this notice. If a set is included on Attachment C as discontinued, identify an alternate BD Alaris" Pump infusion set that is clinically appropriate and specific to the use case. If alternate sets are limited in quantity, they should be prioritized for use in critical-care, neonatal, infant, and pediatric care areas. 1. Review Attachments A, B, C and D and make any necessary adjustments to clinical use or set selection. Forward this communication to all areas of the facility where sets are being used. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. For questions or assistance- contact BD Technical Support at 866-488-1408 Phone hours: 5:00 am to 5:00 pm PT Monday Friday Create a case at: https://bd.com/self-service or [email protected] for clinical questions.

Recall details

Recall number

Z-3080-2026

Status

Open, Classified

Initiated by the company

Aug 19, 2026

Posted by the FDA

Sep 15, 2026

Recalling firm

Bd Switzerland Sarl

Quantity

94,230,757

Product code

FPA

FDA submissions

K022209

Distribution

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

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 AlarisLVP 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

Devices named in this recall

49 devices in the FDA device registry whose identifier appears in the recall's code information.

• Alaris, SmartSite 2420-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls1 death642 reports
• Alaris, SmartSite 11532269

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls332 reports
• Alaris, SmartSite 10010454

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls212 reports
• Alaris 2202-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls248 reports
• Alaris, SmartSite 2477-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls295 reports
• Alaris, SmartSite 10010453

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls165 reports
• Alaris, SmartSite 2432-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls256 reports
• Alaris, SmartSite, Texium 24301-0007T

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls87 reports
• Alaris, SmartSite 11171447

  BD Switzerland Sàrl · Set, administration, intravascular
  4 recalls77 reports
• Alaris, SmartSite 10015012

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls87 reports
• Alaris 2204-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls59 reports
• Alaris 10010483

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls59 reports
• Alaris, SmartSite, Texium 22603-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls54 reports
• Alaris, SmartSite, Texium 24010-0007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls54 reports
• Alaris, SmartSite 2441-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls97 reports
• Alaris 2260-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls96 reports
• Alaris, SmartSite 2465-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls45 reports
• Alaris, SmartSite 10013072

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls33 reports
• Alaris, SmartSite, Texium 24601-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls33 reports
• Alaris, SmartSite 10015861A

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls80 reports
• Alaris, SmartSite, Texium 10013361T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls21 reports
• Alaris, SmartSite, Texium 22000-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls10 reports
• Alaris, SmartSite, Texium 22602-B007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls8 reports
• Alaris, Texium 22600-0007T

  BD Switzerland Sàrl · Set, administration, intravascular
  3 recalls1 report
• Alaris, SmartSite 2423-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls48 reports
• Alaris 10062818

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls34 reports
• Alaris, SmartSite 11426965

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls31 reports
• Alaris 11426964

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls22 reports
• Alaris, SmartSite 10015862

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls21 reports
• Alaris, SmartSite 24600-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls19 reports
• Alaris 2200-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls17 reports
• Alaris, SmartSite 10813621

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls11 reports
• Alaris, SmartSite 10013361

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls9 reports
• Alaris 10013890

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls8 reports
• Alaris, SmartSite 10821753

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls5 reports
• Alaris, SmartSite 10561554

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls4 reports
• Alaris, SmartSite 11404930

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls2 reports
• Alaris, SmartSite, Texium 10321213T

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls2 reports
• Alaris 2206-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls1 report
• Alaris, SmartSite 2466-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls1 report
• Alaris, SmartSite 11419365

  BD Switzerland Sàrl · Set, administration, intravascular
  2 recalls1 report
• Alaris 2278-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall27 reports
• Alaris, VersaSafe 2120-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall14 reports
• Alaris, SmartSite 10015645

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall5 reports
• Alaris 2203-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall2 reports
• Alaris, SmartSite 2455-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall1 report
• Alaris 2210-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall0 reports
• Alaris, SmartSite 2428-0007

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall0 reports
• Alaris, SmartSite 2408-0500

  BD Switzerland Sàrl · Set, administration, intravascular
  1 recall0 reports

Product lines

• Alaris, SmartSiteBD Switzerland Sàrl · 160 models · 10,227 reports · 8 recalls
• AlarisBD Switzerland Sàrl · 85 models · 2,797 reports · 10 recalls
• Alaris, SmartSite, TexiumBD Switzerland Sàrl · 12 models · 291 reports · 5 recalls
• Alaris, VersaSafeBD Switzerland Sàrl · 10 models · 44 reports · 2 recalls