BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general ...

FDA Device Recall #Z-0588-2021 — Class II — November 18, 2020

Recall Summary

Recall Number Z-0588-2021
Classification Class II — Moderate risk
Date Initiated November 18, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Becton Dickinson & Company
Location Franklin Lakes, NJ
Product Type Devices
Quantity 1,430,000

Product Description

BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.

Reason for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of CA, CT, FL, IL, KY, MO, NJ, NY, OH, PA, PR, SC, TN, VA and the countries of Canada, China, Singapore.

Lot / Code Information

Catalog Ref No.: 305106 Lot No:. 9128897 Expiration Date: 2024-06-30 UDI: 30382903051060 Product Package Size: 100 units per carton

Other Recalls from Becton Dickinson & Company

Recall # Classification Product Date
Z-1496-2026 Class II 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. ... Jan 27, 2026
Z-0504-2026 Class II BD Luer Tip Caps; Catalog Number(s) or Model N... Oct 14, 2025
Z-0736-2024 Class II PosiFlush Prefilled Saline Syringe with General... Nov 16, 2023
Z-0349-2024 Class II BD Alaris Pump infusion sets (Product Name, Cat... Oct 11, 2023
Z-0351-2024 Class II BD Extension Sets (Product Name, Catalog #) ... Oct 11, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.