Becton Dickinson Syringe

• • Ongoing Z-1496-2026 FDA Class II ·initiated 27 Jan 2026

  During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

• • Terminated Z-1109-2021 FDA Class II ·initiated 23 Dec 2020

  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.

• • Terminated Z-2007-2019 FDA Class II ·initiated 1 Feb 2019

  The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.

• • Terminated Z-0564-2013 FDA Class II ·initiated 2 Oct 2012

  BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.

• • Terminated Z-0813-2007 FDA Unclassified (pre-2012) ·initiated 9 Apr 2007

  Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity.

• • Terminated Z-0719-2007 FDA Unclassified (pre-2012) ·initiated 15 Feb 2007

  The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.

• 5 recalls, same reason

  • Terminated Z-1057-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1058-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1055-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1054-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005
  • Terminated Z-1056-05 FDA Unclassified (pre-2012) ·initiated 25 May 2005

  The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.

• 4 recalls, same reason

  • Terminated Z-1231-03 FDA Unclassified (pre-2012) ·initiated 4 Aug 2003
  • Terminated Z-1230-03 FDA Unclassified (pre-2012) ·initiated 4 Aug 2003
  • Terminated Z-1232-03 FDA Unclassified (pre-2012) ·initiated 4 Aug 2003
  • Terminated Z-1233-03 FDA Unclassified (pre-2012) ·initiated 4 Aug 2003

  Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile

510(k) Number

K980987 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

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