Medline Luer Slip Syringes Recalled for Inaccurate Volume Delivery
Medline Industries is recalling over 5 million Luer Slip disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity range. This poses a risk to patient health.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a defect affecting dose delivery accuracy. While no injuries or illnesses have been reported and the risk remains theoretical, syringes are critical devices used in direct patient care, and inaccurate volume delivery poses significant potential for patient harm.
Plain-English summary
Medline Industries, LP is recalling the MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE (Model SYR101020) due to a defect in volume accuracy. Testing documentation does not support that these syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity.
The recalled syringes were distributed worldwide, including throughout the United States and to Canada, Panama, the United Arab Emirates, and the U.S. Virgin Islands. Approximately 5,075,234 units are affected. The product identifier (UDI/DI) is 10080196306183, and all affected lots follow the format 897YYMMXXXX.
Inaccurate volume delivery in medical syringes poses a risk to patient health and safety. Healthcare facilities and users should stop using recalled units immediately and contact the manufacturer for replacement or further instructions.
The recalled product
- Product
- MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- inaccurate-dosing
- medical-device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10080196306183
- All lots in the format: 897YYMMXXXX
Distribution
Distributed nationwide across the United States.
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