305127: CE/MDD Class IIa, Becton, Dickinson and Company

Regulatory status

as of registry sync 7 Nov 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-0038290305127LE9 Basic UDI-DI D-0038290305127LE9UDI-DI	Date23 Oct 2026Registered	StatusActive
United States	GUDID listing GUDID	NumberD-0038290305127LE9 UDI-DI	Date16 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK021475	Date19 Jul 2002Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-0038290305127LE9 — open Devices and search for it
AccessGUDID record UDI-DI 00382903051274
FDA 510(k) database 510(k) number K021475

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-0038290305127LE9 registered 23 Oct 2026 Active
FDA 510(k) K021475 decided 19 Jul 2002 Active
FDA GUDID UDI-DI D-0038290305127LE9 listed 16 Sep 2016 Listed

Recalls

3 recalls · FDA

- Terminated Z-0588-2021 FDA Class II initiated 18 Nov 2020
BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
- Terminated Z-0207-2018 FDA Class II initiated 31 May 2017
Hub damage resulting in breakage and/or leakage during use.
- Terminated Z-1009-2012 FDA Unclassified (pre-2012) initiated 8 Oct 2011
Becton Dickinson has identified clogged needles.

Timeline

6 dated events

19 Jul 2002 Cleared FDA 510(k) K021475
8 Oct 2011 Recall initiated FDA recalls Z-1009-2012
16 Sep 2016 Listed FDA GUDID D-0038290305127LE9
31 May 2017 Recall initiated FDA recalls Z-0207-2018
18 Nov 2020 Recall initiated FDA recalls Z-0588-2021
23 Oct 2026 Registered EUDAMED B-0038290305127LE9

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name: PrecisionGlide
Generic name: Hypodermic needle, single-use
Device name: BD PrecisionGlide™ Needle 25G x 1 ½" (0.5mm x 40mm)
Model / Ref / Catalog: 305127

Primary DI / UDI-DI: D-0038290305127LE9 EUDAMED
00382903051274 GUDID
Basic UDI-DI: B-0038290305127LE9
510(k) Number: K021475
FDA product code: FMI
EMDN code: A0101010102 Hypodermic syringe needles, w/o safety systems
GMDN term: Hypodermic needle, single-use

Device class: Class IIa EUDAMED
Class II GUDID
Regulation number: 880.5570
EU registration type: Legacy device (under a directive)
EU market of registration: Belgium
GUDID distribution status: In Commercial Distribution

Size: Needle Gauge — 25 Gauge
Height — 1.5 Inch

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Primary DI / UDI-DI	EUDAMED D-0038290305127LE9	GUDID 00382903051274
Device class	EUDAMED Class IIa	GUDID Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-0038290305127LE9; FDA GUDID lists 00382903051274), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.