HIGHFDA DEVICE

BD 10 mL Luer-Lok Syringe Recalled Over Bundle Packaging Mix-Up in US; 204,000 Units Affected

BD recalled 204,000 10 mL Luer-Lok/Luer Slip syringes due to a packaging mix-up that placed Luer Slip syringes in a batch designated for Luer Lok syringes. The nationwide recall covers products distributed in California and Texas. Healthcare providers and patients should stop using the affected syringes immediately and consult manufacturer recall instructions.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
January 27, 2026
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
January 27, 2026
Hazard Level
HIGH
Brand
Becton Dickinson
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, ELDERLY

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Becton Dickinson
Product type
Luer-Lok / Luer Slip Syringe
Model numbers
Catalog Number: 301029
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    January 27, 2026

  2. Reported by FDA DEVICE

    March 18, 2026

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Becton Dickinson & Company or your healthcare provider for instructions. Notification method: E-Mail

About This Product

BD 10 mL Luer-Lok syringes are used for precise fluid injections and connections in medical settings. They are distributed for clinical use.

Why This Is Dangerous

A mismatch between Luer-Lok and Luer Slip syringes during bulk packaging could affect fit and seal integrity, potentially compromising device performance.

Industry Context

This recall is not described as part of a broader, ongoing pattern in the provided data.

Real-World Impact

Healthcare facilities must verify lot and catalog numbers to prevent usage of mispackaged syringes, potentially causing procedure delays or device incompatibility.

Practical Guidance

How to identify if yours is affected

  1. Locate Catalog Number 301029 on the syringe package or label.
  2. Check Lot Number 5268614 and expiration date 08/31/2030.
  3. Confirm distribution status in your facility or region.

Where to find product info

Recall details and instructions are available on the FDA enforcement page linked in the source.

What timeline to expect

BD will provide next steps, possibly including replacement or refund within the recall process timeline.

If the manufacturer is unresponsive

  • Escalate to hospital compliance or BD medical affairs.
  • Document all correspondence and store the recall notice.

How to prevent similar issues

  • Implement inventory checks for catalog and lot numbers during receiving.
  • Train staff on recognizing Luer-Lok vs Luer Slip syringes.
  • Maintain a batch-control process to prevent mix-ups.

Documentation advice

Keep a copy of the recall notice, batch records, purchase orders, and correspondence with BD.

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Product Details

Catalog Number: 301029. 850 units per case. 204,000 total units recalled. Lot Number: 5268614. Expiration Date: 08/31/2030. Distributed nationwide in the United States, specifically California and Texas.

Reported Incidents

No injuries or incidents have been reported in the recall notice.

Key Facts

  • 204,000 total units recalled
  • CA and TX distribution; nationwide US distribution

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTELDERLY
Injury Types
ELECTRICALLACERATIONOTHER

Product Details

Model Numbers
Catalog Number: 301029
Affected States
ALL
Report Date
March 18, 2026
Recall Status
ACTIVE

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