Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 29, 2023
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 #
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Company recalled BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set V… - a moderate-severity action.
BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set V… was recalled by Becton Dickinson & Company in November 29, 2023. Reason: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).. Check the official notice for the remedy. Verify recall #Z-0349-2024 with the FDA Devices before acting.
The recall
Becton Dickinson & Company issued this moderate-severity FDA Devices recall — Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP)..
- Moderate
- severity level
- Class II
- classification
- November 29, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0349-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0349-2024) was formally reported on November 29, 2023, with the manufacturer initiating the action on October 11, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Becton Dickinson & Company is listed as the recalling firm, operating out of Franklin Lakes, NJ. Federal records list the affected scope as N/A.
The documented reason for this recall is: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). Distribution data in the federal record shows the product reached: 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, P…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
N/A
Related Recalls
6
6 from same agency
Product description
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.
Reason for recall
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0349-2024 |
| Date reported | November 29, 2023 |
| Date initiated | October 11, 2023 |
| Recalling firm | Becton Dickinson & Company |
| Firm location | Franklin Lakes, NJ |
| Affected scope | N/A |
| 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, T… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0349-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Becton Dickinson & Company. Units affected: N/A.
Why was this product recalled? ▼
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0349-2024.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0349-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported November 29, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.