Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417...

FDA Device Recall #Z-0564-2013 — Class II — October 2, 2012

Recall Summary

Recall Number Z-0564-2013
Classification Class II — Moderate risk
Date Initiated October 2, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Becton Dickinson & Company
Location Franklin Lakes, NJ
Product Type Devices
Quantity 2,786,000 units

Product Description

Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.

Reason for Recall

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

Distribution Pattern

(USA) nationwide

Lot / Code Information

Device Listing Number - R060456 REF Lot # 305217 2076404 305217 2055156 305217 2020057 305217 2020056 305219 1346419

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.