Medline Disposable Syringes Recalled for Inaccurate Volume Delivery
Medline is recalling 25.2 million Luer Lock disposable syringes because testing documentation does not confirm they deliver accurate volumes across their claimed capacity. The inaccuracy may pose a risk to patient health.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II device with documented testing inadequacy regarding volume accuracy. Classified as a risk-of-harm product per the severity rubric, limited to score 3 because no illnesses or injuries have been reported.
Plain-English summary
Medline Industries, LP is recalling 25,214,334 Luer Lock Disposable Syringes (Model SYR101010) due to testing documentation concerns. Testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity.
The affected syringes have been distributed worldwide, including throughout the United States and in Canada, Panama, United Arab Emirates, and the U.S. Virgin Islands. All affected lots follow the format 897YYMMXXXX.
The inability to confirm volume delivery accuracy across the claimed capacity range may pose a risk to patient health.
The recalled product
- Product
- MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Syringe
- Affected units
- 25,214,334
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 10884389596319
- All lots in the format: 897YYMMXXXX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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