Bd Switzerland Sarl: Set, Administration, Intravascular

BD is recalling multiple models of Alaris Pump Infusion Sets distributed nationwide and internationally because performance data discrepancies may cause the infusion pump to operate improperly. The recall affects infusion sets used with BD Alaris pumps in the United States and over 30 other countries including Canada, Australia, and various European and Middle Eastern nations.

Recalling firm
BD SWITZERLAND SARL
Product
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,...
Reason
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-08-19
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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...

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/cf323ad8-4afc-4df3-ac3d-3bb3e8d0d5b9