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Use caution Medical device recall · FDA · Published February 28, 2019

Becton Dickinson SmartSite Syringe Set Recall: Leaking Risk

Becton Dickinson recalls SmartSite Syringe Administration Sets (50-pack) due to leaking risk, which may cause infusion delays, under-infusion, or contamination. Affected units have specific catalog and lot numbers.

🇺🇸 FDA recall #Z-1210-2019Medical deviceBecton Dickinson ›
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Recalling firmBecton Dickinson & Company1 Becton Dr · Franklin Lakes, NJ 07417-1815
✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling SmartSite Syringe Administration Sets (50-pack) because they can leak, potentially causing infusion delays, under-infusion, or contamination. This affects healthcare professionals using the product for medical treatments. Read more at govinfonow.com/recall/68927-becton-dickinson-smartsite-syringe-set-recall-leaking-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/68927-becton-dickinson-smartsite-syringe-set-recall-leaking-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1210-2019

Cite this page

“Becton Dickinson SmartSite Syringe Set Recall: Leaking Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68927-becton-dickinson-smartsite-syringe-set-recall-leaking-risk. Based on FDA recall #Z-1210-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1210-2019%22&limit=1).

The FDA announced on Feb. 28, 2019, that Becton Dickinson & Company voluntarily recalled SmartSite Syringe Administration Sets due to leaking hazards. The agency issued recall number Z-1210-2019 for the affected medical devices.

How to tell if you have it

  • Brand: Becton Dickinson
  • Product: SmartSite Syringe Administration Set-Product Package Size 50
  • Catalog Number: 10798696
  • Lot Number: 18046218
  • Expiration Date: 04/18/2021
  • UDI: 50885403234352

The hazard

The SmartSite Syringe Administration Sets may leak, potentially resulting in delay or interruption of infusion, under-infusion, contamination of the fluid path, and healthcare provider exposure to infusates. The record does not report specific incidents or injuries associated with this recall.

Context

GovInfoNow's records show Becton Dickinson & Company has 52 other recalls on file since May 31, 2017. Recent brand recalls include a spinal tray recall dated April 27, 2026, and a non-sterile Luer-Lok syringe recall dated Jan. 27, 2026. Other recent recalls of similar products include the Swan-Ganz Jr Catheter Recall (April 8, 2026) and the Swan-Ganz Catheter Recall (April 8, 2026).

How to tell if you have this one

Check for the catalog number 10798696 and lot number 18046218 on the product packaging. The product was sold with an expiration date of April 18, 2021.

  • Brand
    Becton Dickinson
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the catalog number 10798696 and lot number 18046218 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide Distribution in the states of AR, NH, NC” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, New Hampshire, North Carolina.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

1. Firm started the recall: Feb 28, 201912. FDA classified it Class I: Jun 26, 201923. Published in FDA’s Enforcement Report: Jul 3, 201934. FDA terminated the recall: Jul 30, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-1210-2019 (February 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1210-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA