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Lower risk Medical device recall · FDA · Published December 23, 2020

BD Hypodermic Syringe 10ml Risk: Open Packaging May Compromise Sterility

Becton Dickinson recalls 10ml eccentric tip syringes with open seals that could compromise sterility. Affected units have catalog number 305482 and expire May 2023. Consumers should check packaging for open seals.

🇺🇸 FDA recall #Z-1109-2021Medical 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 10ml eccentric tip syringes that may have open seals in the packaging. This could compromise the sterility of the syringe, making it unsafe for medical use. Read more at govinfonow.com/recall/63621-bd-hypodermic-syringe-10ml-risk-open-packaging-may-compromise-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/63621-bd-hypodermic-syringe-10ml-risk-open-packaging-may-compromise-sterility · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1109-2021

Cite this page

“BD Hypodermic Syringe 10ml Risk: Open Packaging May Compromise Sterility.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63621-bd-hypodermic-syringe-10ml-risk-open-packaging-may-compromise-sterility. Based on FDA recall #Z-1109-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1109-2021%22&limit=1).

The FDA announced on Dec. 23, 2020, that Becton Dickinson & Company voluntarily recalled BD Hypodermic Syringes with eccentric tips due to open seals that may compromise sterility. The recall involves 155,200 units distributed nationwide in the U.S. and Canada.

How to tell if you have it

  • Brand: Becton Dickinson
  • Product: BD Hypodermic Syringe 10 ml, eccentric tip
  • Catalog (Ref No.): 305482
  • Lot #: 8142303
  • Expiration date: 31-May-2023
  • UDI: 00382903054824

The hazard

The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.

Context

GovInfoNow's records show Becton Dickinson & Company has 52 other recalls on record since May 31, 2017. Other recent recalls include a Jan. 27, 2026 recall of 10mL Non-Sterile Luer-Lok Syringes due to wrong syringe type and an Oct. 14, 2025 recall of Luer Tip Caps for failed biocompatibility testing. Similar product recalls include Dec. 24, 2025 Medline Sterile Resuture Pack Kits, Medline Anesthesia Artline Packs, and Medline Medical Kits, all citing open seal risks.

How to tell if you have this one

Check for open seals on the packaging. Affected syringes have catalog number 305482 and expire May 2023. The product was sold with lot number 8142303.

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

What to do — step by step

  1. Check Packaging Seal

    Inspect the syringe packaging for open seals. If the seal is broken, the syringe may not be sterile.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Distribution US nationwide and Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Dec 23, 202012. FDA classified it Class II: Feb 12, 202123. Published in FDA’s Enforcement Report: Feb 24, 202134. FDA terminated the recall: Nov 21, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class II
  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-1109-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1109-2021 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.
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