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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Home Healthcare

Becton Dickinson & Company: Saline Syringes Recalled for Incorrect Stopper and Injection Force Risk

Agency Publication Date: January 17, 2024
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Summary

Becton Dickinson & Company has recalled 5,085,120 units of PosiFlush Prefilled Saline Syringes with General Pump Compatibility due to the use of an incorrect stopper during manufacturing. This defect causes an increase in the force required to inject the saline, which can trigger unexpected alarms when the syringes are used with a syringe pump. This recall affects nine specific lots of the 10mL syringes used for flushing medical devices. Consumers and healthcare providers should check their inventory immediately for the affected catalog and lot numbers.

Risk

The incorrect stopper creates excessive resistance during injection; if used with a syringe pump, this increased force can trigger occlusion alarms, potentially delaying necessary medical treatment or requiring healthcare staff to troubleshoot equipment during critical care.

What You Should Do

  1. Identify your product by checking for the PosiFlush Prefilled Saline Syringe (10mL Syringe with 10mL Saline Fill), Catalog Number 306547.
  2. Check the packaging for UDI-DI 30382903065470 and one of the following nine affected lot numbers: 3207548, 3207555, 3214826, 3226386, 3214828, 3226388, 3250302, 3250303, or 3250304.
  3. Immediately quarantine and stop using any syringes matching these specific lot numbers to prevent pump alarms or injection delays.
  4. Contact your healthcare provider or the manufacturer, Becton Dickinson & Company, at their Franklin Lakes, NJ headquarters for instructions on returning the affected units and receiving a replacement or refund.
  5. For additional information or questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill)
Model / REF:
Catalog Number 306547
UDI-DI: 30382903065470
Lot Numbers:
3207548
3207555
3214826
3226386
3214828
3226388
3250302
3250303
3250304

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93562
Status: Active
Manufacturer: Becton Dickinson & Company
Sold By: Hospital suppliers; Medical distributors
Manufactured In: United States
Units Affected: 5,085,120 units
Distributed To: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.