# K980987: Becton Dickinson Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jun 11, 1998 after 86 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
113 later devices descend from it; 18 cite it directly.
2 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Single Use Hypodermic Syringes: named in the summary without a submission number

## Most influential descendants
- K070264: 50 ML Terumo Syringe for Administration of UV Sensitive Medicines, Model BS-50LB (2007), 35 descendants of its own
- K083514: Terumo Syringe with/Without Needle (2009), 34 descendants of its own
- K112434: BD Oral/Enteral Syringe with BD Univia Connection (2011), 33 descendants of its own
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (2017), 32 descendants of its own
- K142128: Kangaroo Enteral Feeding Syringes with Enfit Connector (2015), 31 descendants of its own

## Recalls of this device
- Jan 27, 2026 · Class II · Z-1496-2026: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
- Dec 23, 2020 · Class II · Z-1109-2021: 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.
- Feb 1, 2019 · Class II · Z-2007-2019: 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.
- Oct 2, 2012 · Class II · Z-0564-2013: BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
- Apr 9, 2007 · Not classified · Z-0813-2007: 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.
- Feb 15, 2007 · Not classified · Z-0719-2007: 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.
- May 25, 2005 · Not classified · Z-1054-05: The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- May 25, 2005 · Not classified · Z-1058-05: The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- May 25, 2005 · Not classified · Z-1055-05: The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- May 25, 2005 · Not classified · Z-1056-05: The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- May 25, 2005 · Not classified · Z-1057-05: The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- Aug 4, 2003 · Not classified · Z-1231-03: Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
- Aug 4, 2003 · Not classified · Z-1232-03: Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
- Aug 4, 2003 · Not classified · Z-1233-03: Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile
- Aug 4, 2003 · Not classified · Z-1230-03: Mislabeled kit: Prefilled Lidocaine syringe is labeled 'sterile fluid path only', outer label states kit content is sterile

## Indications for use
These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection.

Source page: https://510kreport.com/device/K980987
Methodology: https://510kreport.com/methodology