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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/Surgical Equipment

Medline Contro-Bulb Syringes Recalled for Potential Sterile Barrier Breach

Agency Publication Date: September 30, 2024
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Summary

Medline Industries, LP is recalling 4,831 units of the Medline Contro-Bulb Syringe (REF DYND20125) because a packaging update may have caused the sterile barrier to fail during shipping. The recall specifically affects syringes with lot numbers 96922110001 and 96923100001. No injuries or medical incidents have been reported at this time.

Risk

A breach in the sterile packaging can allow the irrigation syringe to become contaminated. Using a non-sterile syringe during medical procedures increases the risk of infection for the patient.

What You Should Do

  1. This recall affects Medline Contro-Bulb Syringes (bulb irrigation syringes) with model number REF DYND20125 and lot numbers 96922110001 or 96923100001.
  2. Check the model number and lot number printed on the device or case packaging to determine if your inventory is affected.
  3. Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Contro-Bulb Syringe
Variants: Bulb irrigation syringe
Model / REF:
DYND20125
Lot Numbers:
96922110001
96923100001
UDI:
40080196031765
10080196031764

Total units affected: 4,831. UDI corresponds to case and unit levels.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93795
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; Medical supply distributors
Manufactured In: United States
Units Affected: 4831 units
Distributed To: Nationwide

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.