Stop using nowMedical device recall · FDA · Published October 11, 2023
BD Gravity Sets Contain DEHP - Risk of Harm to Patients
Becton Dickinson recalls gravity sets that label themselves as DEHP-free but actually contain di(2-ethylhexyl) phthalate (DEHP). Affected sets have catalog numbers 4030B-07T and 42081E, sold through July 31, 2026.
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Take action
Contact the company
📍Recalling firmBecton Dickinson & Company1 Becton Dr · Franklin Lakes, NJ 07417-1815
✎ GovInfoNow plain-language explainer
Becton Dickinson is recalling gravity sets that claim to be DEHP-free but actually contain di(2-ethylhexyl) phthalate (DEHP). This chemical can harm patients during medical treatments, so affected users should stop using the sets immediately. Read more at govinfonow.com/recall/57092-bd-gravity-sets-contain-dehp-risk-of-harm-to-patients.
“BD Gravity Sets Contain DEHP - Risk of Harm to Patients.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57092-bd-gravity-sets-contain-dehp-risk-of-harm-to-patients. Based on FDA recall #Z-0350-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0350-2024%22&limit=1).
Becton Dickinson & Company recalled BD gravity infusion sets labeled as DEHP-free but containing di(2-ethylhexyl) phthalate, the FDA said on Oct. 11, 2023. The Class II recall affects products distributed worldwide.
How to tell if you have it
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T
BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E
The hazard
Affected infusion sets labeled as free of DEHP actually contain di(2-ethylhexyl) phthalate (DEHP).
Context
GovInfoNow's records show Becton Dickinson & Company has 52 other recalls on record since May 31, 2017. Other recent recalls of similar products include Becton Dickinson Spinal Tray Recall: Quality Issues from FDA Inspection (April 27, 2026) and Becton Dickinson 10mL Non-Sterile Luer-Lok Syringes Recalled Due to Wrong Syringe Type (Jan. 27, 2026).
How to tell if you have this one
Check for catalog numbers 4030B-07T or 42081E on the product label. The sets were sold from the manufacturer's production date through July 31, 2026.
Brand
Becton Dickinson
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WY, Puerto Rico, Guam; and the countries of Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, United Arab Emirates.
Recall number
Product, codes & lots
Z-0349-2024
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010454; BD AlarisTM Pump Infusion Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSiteTM Y-sites, Catalog # 10013072; BD AlarisTM Bag Access Non-Vented Back Check Valve 2 SmartSiteTM Y-Sites, Catalog # 10013361; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 10013890; BD AlarisTM Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSiteTM Port (Burette) SmartSiteTM Y-Site, Catalog # 10015012; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE-Lined), Catalog # 10015862; BD AlarisTM Pump Infusion Blood Set 180 Micron Filter 2 Blunt Spikes, Catalog # 10062818; BD AlarisTM Pump Infusion Buerette Set SmartSiteTM Port (Burette) 3 SmartSiteTM Y-Sites, Catalog # 10821753; BD AlarisTM Pump Infusion Set 2 Back Check Valves 3 SmartSiteTM Y-Sites, Catalog # 11171447; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 11426964; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Back Check Valve Low Sorbing Tubing (PE Lined) 2 SmartSiteTM Y-sites, Catalog # 11532269; BD AlarisTM Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSiteTM Port (Burette) 2 SmartSiteTM Y-Sites, Catalog # 11613191; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog # 10015861A; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM ClosedMale LuerWith PrimingCAP, Catalog # 22000-B007T; BD AlarisTM Pump Infusion Set 1.2 Micron Filter, Catalog # 2202-0007; BD AlarisTM Pump Infusion Set, Catalog # 2204-0007; BD AlarisTM Pump Infusion Set Yellow-Striped Microbore Tubing, Catalog # 2206-0007; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined), Catalog # 2260-0500; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22600-0007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22601-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22602-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined) Bonded TexiumTM with priming cap, Catalog # 22603-B007T; BD AlarisTM Pump Infusion Set Back Check Valve SmartSiteTM Y-site, Catalog # 24001-0007; BD AlarisTM Pump Infusion Set Half Set SmartSiteTM Y-site, Catalog # 2403-0007; BD AlarisTMPumpInfusionSetSmartsiteTM BagAcessNon-Vented0.2MicronFilterBondedTexiumTMClosedLowSorbingTubing(PELined)MaleLuerwithprimingcapSmartSiteTMY-site, Catalog # 24301-0007T; BD AlarisTM Pump Infusion Buerette Set Smallbore Tubing SmartsiteTM Port (Burette) 3 SmartSiteTM Y-Site, Catalog # 2441-0007; BD AlarisTM Pump Infusion Set Back Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSiteTM Y-sites, Catalog # 2450-0500; BD AlarisTM Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 3 SmartSiteTM Y-Sites, Catalog # 24600-0007; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing TexiumTM Back Check Valve 2 SmartSiteTM Y-sites, Catalog # 24601-B007T; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented 0.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-Site, Catalog # 2465-0007; BD AlarisTM Pump Infusion Set SmartSiteTM Bag Access Non-Vented Low Sorbing Tubing (PE Lined), Catalog # 2466-0007.; UDI-DI: 10885403232602, Catalog # 10010483; UDI-DI: 07613203021135, Catalog # 10010453; UDI-DI: 07613203015806, Catalog # 10010454; UDI-DI: 07613203021210, Catalog # 10013072; UDI-DI: 10885403221965, Catalog # 10013361; UDI-DI: 10885403232268, Catalog # 10013890; UDI-DI: 10885403233951, Catalog # 10015012; UDI-DI: 10885403221866, Catalog # 10015862; UDI-DI: 07613203019668, Catalog # 10062818; UDI-DI: 07613203019187, Catalog # 10821753; UDI-DI: 07613203021234, Catalog # 11171447; UDI-DI: 10885403232367, Catalog # 11426964; UDI-DI: 10885403232343, Catalog # 11532269; UDI-DI: 10885403276026, Catalog # 11613191; UDI-DI: 10885403232626, Catalog # 10015861A; UDI-DI: 10885403245022, Catalog # 22000-B007T; UDI-DI: 10885403274039, Catalog # 2202-0007; UDI-DI: 10885403199363, Catalog # 2204-0007; UDI-DI: 07613203019224, Catalog # 2206-0007; UDI-DI: 07613203012591, Catalog # 2260-0500; UDI-DI: 10885403239595, Catalog # 22600-0007T; UDI-DI: 10885403240966, Catalog # 22601-B007T; UDI-DI: 10885403240935, Catalog # 22602-B007T; UDI-DI: 10885403240942, Catalog # 22603-B007T; UDI-DI: 10885403238666, Catalog # 24001-0007; UDI-DI: 10885403232473, Catalog # 2403-0007; UDI-DI: 10885403223198, Catalog # 24301-0007T; UDI-DI: 10885403235047, Catalog # 2441-0007; UDI-DI: 10885403235115, Catalog # 2450-0500; ; UDI-DI: 10885403241970, Catalog # 24600-0007; UDI-DI: 10885403240959, Catalog # 24601-B007T; UDI-DI: 10885403221941, Catalog # 2465-0007; UDI-DI: 10885403221958, Catalog # 2466-0007. All lots, expiration date thru July 31, 2026.
Z-0350-2024
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.; UDI-DI: 10885403240867, Catalog # 4030B-07T; UDI-DI: 07613203020855, Catalog # 42081E. All lots, thru expiration date July 31, 2026.
Z-0351-2024
BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.; UDI-DI: 10885403233814, Catalog # 10013902 UDI-DI: 07613203011853, Catalog # 20062E; UDI-DI: 10885403226120, Catalog # 70000N-07; UDI-DI: 10885403236112, Catalog # ME1224; UDI-DI: 10885403229756, Catalog # 20350ET; UDI-DI: 10885403240997, Catalog # 70001B-07T. All lots, thru expiration date October 16, 2026.
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discontinue use of the affected gravity sets as they contain DEHP, which can harm patients during medical treatments.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0350-2024 (October 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0350-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.