HIGHFDA DEVICE

BD Catheter Recalled Due to Incorrect Expiration Labeling

BD recalled 149,310 hydrophilic catheters due to a labeling error regarding expiration dates. The recall affects the 14 Fr (4.7 mm) straight tip model, REF: RTU14F. Healthcare providers and patients must stop using the product immediately.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
November 29, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
November 29, 2025
Hazard Level
HIGH
Brand
HANGZHOU BEVER MEDICAL DEVICES CO.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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
HANGZHOU BEVER MEDICAL DEVICES CO.
Product type
Hydrophilic Catheter
Model numbers
UDI: (01)06948796204063/Lot # T21823
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    November 29, 2025

  2. Reported by FDA DEVICE

    January 21, 2026

  3. RecallRadar source check

    January 28, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Labeling error, Incorrect expiration date

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact HANGZHOU BEVER MEDICAL DEVICES CO., LTD. or your healthcare provider for instructions. Notification method: Letter

About This Product

The BD Ready-to-Use Hydrophilic Catheter is designed for patients requiring intermittent catheterization. Consumers typically buy this product for convenience and ease of use in managing urinary retention or incontinence.

Why This Is Dangerous

The incorrect labeling of expiration dates can lead to patients using a catheter that is no longer safe, increasing the risk of infection or device failure.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers must stop using the product immediately, which may cause inconvenience and require obtaining a replacement.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on your catheter against the recall information.
  2. Verify that your catheter is the BD Ready-to-Use Hydrophilic Catheter, 14 Fr (4.7 mm).
  3. Confirm the expiration date on the packaging.

Where to find product info

The lot number can usually be found on the packaging or the catheter box.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Contact the manufacturer again and keep a record of your attempts.
  • Reach out to your healthcare provider for assistance.
  • File a complaint with the FDA if necessary.

How to prevent similar issues

  • Always check expiration dates on medical devices before use.
  • Look for FDA-approved labels and certifications when purchasing medical devices.
  • Stay updated on recalls for any medical products you use.

Documentation advice

Keep a copy of your purchase receipt, any correspondence with the manufacturer, and photos of the product as evidence.

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Product Details

The recall involves the BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female, REF: RTU14F. Approximately 149,310 units are affected, distributed nationwide in the U.S., particularly in Georgia. The catheters were sold under the brand Hangzhou Bever Medical Devices Co.

Key Facts

  • Class II recall
  • High hazard level
  • Stop using immediately
  • Contact manufacturer for instructions
  • Nationwide distribution in the U.S.

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
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI: (01)06948796204063/Lot # T21823
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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