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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

MEDLINE INDUSTRIES, LP - Northfield: Medline Disposable Syringes Recalled Due to Potential Inaccurate Volume Delivery

Agency Publication Date: May 31, 2024
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Summary

Medline Industries is recalling approximately 30.2 million Luer Lock and Luer Slip disposable syringes because testing documentation does not guarantee they can accurately deliver the correct volume of medicine across their entire graduated range. This issue affects over 25 million Luer Lock syringes (model SYR101010) and over 5 million Luer Slip syringes (model SYR101020) manufactured in the United States. If these syringes are used to measure and deliver medication, patients may receive more or less than the intended dose. You should check your medical supplies for these specific Medline models and contact your healthcare provider or the manufacturer regarding next steps.

Risk

The syringes may deliver inaccurate volumes of medication because their design and testing do not support accurate measurement across their full labeled capacity. This could lead to dosing errors, potentially resulting in patient harm or ineffective treatment depending on the medication being administered.

What You Should Do

  1. Identify your syringes by checking the packaging for the product names: MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE (REF SYR101010) or MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE (REF SYR101020).
  2. Check the lot numbers on the packaging to see if they follow the format 897YYMMXXXX, and look for UDI/DI codes 10884389596319 or 10080196306183.
  3. If you have these syringes, contact your healthcare provider for advice on alternative products and to discuss any concerns regarding previous use of these devices.
  4. Contact Medline Industries, LP directly at their Northfield, Illinois headquarters for specific instructions on how to handle or return affected stock.
  5. Call the FDA's consumer hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE
Model / REF:
REF SYR101010
UDI/DI 10884389596319
Lot Numbers:
All lots in the format: 897YYMMXXXX
Product: MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE
Model / REF:
REF SYR101020
UDI/DI 10080196306183
Lot Numbers:
All lots in the format: 897YYMMXXXX

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94537
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline Industries; medical distributors
Manufactured In: United States
Units Affected: 2 products (25,214,334 syringes; 5,075,234 syringes)
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.