HIGH

Medline Recalls 8.2M Saline Flush Syringes Over Concentration Issues

Medline Industries recalled 8,267,150 saline flush syringes on September 11, 2025. The syringes may not meet the required concentration of sodium chloride. Consumers and healthcare providers must stop using these products immediately.

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Product Details

The recalled product is 0.9% Sodium Chloride Injection, USP, with a 10 mL fill and item number EMZ111240. The syringes were distributed nationwide in the U.S. and Canada.

The Hazard

The recalled saline IV flush syringes may not contain the correct sodium chloride concentration. This poses a risk of improper dosing in medical treatments.

Reported Incidents

No specific injury reports have been recorded. The high hazard level indicates serious potential risks associated with improper use.

What to Do

Stop using the recalled syringes immediately. Contact Medline Industries or your healthcare provider for further instructions and guidance.

Contact Information

For more information, call Medline Industries at 1-800-396-2006 or visit their website at https://www.medline.com.

Key Facts

  • Recall date: September 11, 2025
  • Distribution: U.S. and Canada
  • Quantity recalled: 8,267,150 syringes
  • Hazard level: HIGH

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSaline Injection Syringes
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI (Case): 10363807000039
UDI (Box): 363807000032
UDI (Each): 363807100114
Lot Numbers: 25AJA049
25BJA001
+4 more
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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